Trial Outcomes & Findings for Mild Hypothermia and Acute Kidney Injury in Liver Transplantation (NCT NCT03534141)
NCT ID: NCT03534141
Last Updated: 2025-05-16
Results Overview
Acute Kidney Injury (AKI) is defined according to the International Club for Ascites (ICA) 2015 criteria, a revision of the Kidney Disease Improving Global Outcome (KDIGO) criteria for patients with cirrhosis (Angeli P, Ginès P, Wong F, Bernardi M, Boyer TD, Gerbes A, et al. Gut. 2015 Apr;64(4):531-7). AKI is defined as an increase in sCr ≥ 0.3 mg/dL within 48 hours, or a percentage increase ≥ 50% from baseline, or the initiation of renal replacement therapy. Baseline creatinine is defined as the most recent value obtained prior to liver transplantation.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
72 hours from the end of surgery
Results posted on
2025-05-16
Participant Flow
Subjects were recruited between July 2018 and August 2023 from patients scheduled for deceased donor liver transplantation at three transplant centers.
Participants were enrolled after liver transplantation was scheduled but before entering the operating room for surgery. Before proceeding with randomization, it was necessary for the attending surgeon to verify that the liver graft was suitable for transplantation. If that was not the case, the transplant could be aborted before randomization.
Participant milestones
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube and is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
88
|
|
Overall Study
COMPLETED
|
86
|
85
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube and is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Overall Study
Enrolled in other clinical trial
|
1
|
0
|
|
Overall Study
Liver transplant aborted after randomization
|
0
|
2
|
|
Overall Study
Liver graft explanted due to surgical issue
|
0
|
1
|
Baseline Characteristics
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Baseline characteristics by cohort
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=86 Participants
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube and is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=85 Participants
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=99 Participants
|
59 years
n=107 Participants
|
59 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=99 Participants
|
85 participants
n=107 Participants
|
171 participants
n=206 Participants
|
|
Etiology of liver disease
Hepatitis C
|
17 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Etiology of liver disease
Hepatitis B
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Etiology of liver disease
Alcoholic
|
22 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Etiology of liver disease
Nonalcoholic steatohepatitis (NASH)
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Etiology of liver disease
Cryptogenic
|
2 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Etiology of liver disease
Other
|
19 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Model for End-stage Liver Disease-Sodium score
|
21 units on a scale
n=99 Participants
|
22 units on a scale
n=107 Participants
|
22 units on a scale
n=206 Participants
|
|
Body Mass Index
|
27.6 kg/m^2
n=99 Participants
|
27.2 kg/m^2
n=107 Participants
|
27.3 kg/m^2
n=206 Participants
|
PRIMARY outcome
Timeframe: 72 hours from the end of surgeryPopulation: Intention-to-treat population. Excludes participants that were withdrawn after randomization.
Acute Kidney Injury (AKI) is defined according to the International Club for Ascites (ICA) 2015 criteria, a revision of the Kidney Disease Improving Global Outcome (KDIGO) criteria for patients with cirrhosis (Angeli P, Ginès P, Wong F, Bernardi M, Boyer TD, Gerbes A, et al. Gut. 2015 Apr;64(4):531-7). AKI is defined as an increase in sCr ≥ 0.3 mg/dL within 48 hours, or a percentage increase ≥ 50% from baseline, or the initiation of renal replacement therapy. Baseline creatinine is defined as the most recent value obtained prior to liver transplantation.
Outcome measures
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=86 Participants
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=85 Participants
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Acute Kidney Injury (AKI)
|
56 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 72 hours from the end of surgeryPopulation: Intention-to-treat population. Excludes participants that were withdrawn after randomization.
The International Club for Ascites (ICA) 2015 criteria, a revision of the Kidney Disease Improving Global Outcome (KDIGO) criteria for patients with cirrhosis (Angeli P, Ginès P, Wong F, Bernardi M, Boyer TD, Gerbes A, et al. Gut. 2015 Apr;64(4):531-7), will be used to define the stage of AKI (Stage 1, 2, or 3). The distribution of the stages of AKI within 72 hours after liver transplantation. The stages of AKI are defined as follows based on the serum creatinine (sCr): AKI Stage 1: increase in sCr ≥ 0.3 mg/dL, or an increase in sCr ≥ 1.5-fold and ≤ 2-fold from baseline. AKI Stage 2: increase in sCr \> 2-fold and ≤ 3-fold from baseline. AKI Stage 3: increase in sCr \> 3-fold from baseline, or sCr ≥ 4.0 with an acute increase of ≥ 0.3 mg/dL, or initiation of renal replacement therapy.
Outcome measures
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=86 Participants
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=85 Participants
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Distribution of the Stages of Acute Kidney Injury (AKI)
No AKI
|
30 Participants
|
38 Participants
|
|
Distribution of the Stages of Acute Kidney Injury (AKI)
AKI Stage 1
|
32 Participants
|
20 Participants
|
|
Distribution of the Stages of Acute Kidney Injury (AKI)
AKI Stage 2
|
13 Participants
|
9 Participants
|
|
Distribution of the Stages of Acute Kidney Injury (AKI)
AKI Stage 3
|
11 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Time from end of liver transplant to ICU discharge, approximately 1 to 3 daysPopulation: Intention-to-treat population. Excludes participants that were withdrawn after randomization.
Time after liver transplantation until patient is discharged from the ICU to a regular hospital bed.
Outcome measures
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=86 Participants
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=85 Participants
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Duration of Intensive Care Unit (ICU) Stay
|
36 hours
Interval 0.0 to 70.0
|
37 hours
Interval 19.0 to 68.0
|
SECONDARY outcome
Timeframe: Time from liver transplant to hospital discharge, approximately 1-2 weeks.Population: Intention-to-treat population. Excludes participants that were withdrawn after randomization.
From the date of liver transplantation until the date patient is discharged from the hospital.
Outcome measures
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=86 Participants
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=85 Participants
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Duration of Hospital Stay
|
7 days
Interval 5.0 to 9.0
|
7 days
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Intention-to-treat population. Excludes participants that were withdrawn after randomization.
From the date of liver transplantation until the date of death from any cause.
Outcome measures
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=86 Participants
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=85 Participants
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Patient Survival
|
81 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: 72 hours, 30 days, and 1 year. The original protocol specified assessment at 1 week after surgery. However, this data was unable to be collected and we are only able to determine the outcome at 72 hours, 30 days, and 1 year.Population: Intention-to-treat population. Excludes participants that were withdrawn after randomization.
Patient is receiving continuous renal replacement therapy or dialysis at the time of follow-up. If patient died before the indicated follow-up time, the outcome was counted as positive (patient was on renal replacement therapy).
Outcome measures
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=86 Participants
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=85 Participants
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Need for Renal Replacement Therapy
Renal replacement therapy within 72 hours after liver transplant.
|
8 Participants
|
13 Participants
|
|
Need for Renal Replacement Therapy
Renal replacement therapy at 30 days after liver transplant.
|
8 Participants
|
5 Participants
|
|
Need for Renal Replacement Therapy
Renal replacement therapy at 1 year after liver transplant.
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 90 days and 1 yearPopulation: Intention-to-treat population. Excludes participants that were withdrawn after randomization.
Presence of a reduction in GFR by ≥ 25 mL/min or ≥ 50% from baseline at the time of follow-up. If patient died before the indicated follow-up time, the outcome was counted as positive (patient had persistent renal dysfunction).
Outcome measures
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=86 Participants
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=85 Participants
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Persistent Renal Dysfunction
Persistent renal dysfunction at 90 days after liver transplant.
|
24 Participants
|
25 Participants
|
|
Persistent Renal Dysfunction
Persistent renal dysfunction at 1 year after liver transplant.
|
28 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Baseline (start of surgery) and 2 hours after reperfusion of the portal veinPopulation: Serum for NGAL determination was only collected at the coordinating center. It was not feasible to collect serum for all patients due to research personnel being unavailable during some off-hours and weekend liver transplants.
Change in serum NGAL levels from baseline to 2 hours after reperfusion of the portal vein (final - initial).
Outcome measures
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=37 Participants
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=38 Participants
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Serum Neutrophil Gelatinase-associated Lipocalin (NGAL)
|
20.8 ng/mL
Interval 1.8 to 61.4
|
26.15 ng/mL
Interval 7.0 to 44.9
|
SECONDARY outcome
Timeframe: Baseline (start of surgery) and 2 hours after reperfusion of the portal veinPopulation: Urine for NGAL determination was only collected at the coordinating center. It was not feasible to collect urine for all patients due to research personnel being unavailable during some off-hours and weekend liver transplants.
Change in urine NGAL levels from baseline to 2 hours after reperfusion of the portal vein (final - initial).
Outcome measures
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=39 Participants
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=40 Participants
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Urine Neutrophil Gelatinase-associated Lipocalin (NGAL)
|
156.3 ng/mL
Interval 8.2 to 491.7
|
81.85 ng/mL
Interval 5.8 to 250.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During surgeryPopulation: Intention-to-treat population. Excludes participants that were withdrawn after randomization.
The number of units of packed red blood cells, fresh frozen plasma, platelets, and cryoprecipitate transfused during surgery. We had originally proposed to measure up until 72 hours after surgery, but we were not able to collect this data at all centers. Therefore, only blood product transfusions during surgery are reported.
Outcome measures
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=86 Participants
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=85 Participants
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Blood Product Transfusions
Packed red blood cells
|
4 Units of blood product transfused
Interval 1.0 to 7.0
|
5 Units of blood product transfused
Interval 1.0 to 8.0
|
|
Blood Product Transfusions
Fresh frozen plasma
|
8.5 Units of blood product transfused
Interval 3.0 to 14.0
|
9 Units of blood product transfused
Interval 3.0 to 18.0
|
|
Blood Product Transfusions
Platelets
|
2 Units of blood product transfused
Interval 0.0 to 2.0
|
2 Units of blood product transfused
Interval 0.0 to 3.0
|
|
Blood Product Transfusions
Cryoprecipitate
|
0 Units of blood product transfused
Interval 0.0 to 1.0
|
0 Units of blood product transfused
Interval 0.0 to 1.0
|
Adverse Events
Mild Hypothermia & Esophageal Cooling/Warming Device
Serious events: 5 serious events
Other events: 15 other events
Deaths: 5 deaths
Normothermia & Esophageal Cooling/Warming Device
Serious events: 3 serious events
Other events: 15 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=86 participants at risk
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=85 participants at risk
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Hepatobiliary disorders
Primary non-function of the liver
|
1.2%
1/86 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
1.2%
1/85 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Blood and lymphatic system disorders
Inferior vena cava thrombus
|
1.2%
1/86 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
0.00%
0/85 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Cardiac disorders
Intraoperative cardiac arrest
|
2.3%
2/86 • Number of events 2 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
1.2%
1/85 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Infections and infestations
Disseminated fungal infection leading to death
|
1.2%
1/86 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
1.2%
1/85 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
Other adverse events
| Measure |
Mild Hypothermia & Esophageal Cooling/Warming Device
n=86 participants at risk
The target core temperature is 34-35 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
|
Normothermia & Esophageal Cooling/Warming Device
n=85 participants at risk
The target core temperature is 36.5-37.5 °C.
Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding (significant) with refractory severe coagulopathy
|
3.5%
3/86 • Number of events 3 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
1.2%
1/85 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Gastrointestinal disorders
Bleeding, upper gastrointestinal with esophageal temperature management device insertion
|
0.00%
0/86 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
0.00%
0/85 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
General disorders
Hypothermia, severe
|
1.2%
1/86 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
0.00%
0/85 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Injury, poisoning and procedural complications
Oropharyngeal, dental, or esophageal trauma
|
0.00%
0/86 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
2.4%
2/85 • Number of events 2 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Product Issues
Perforation or damage to esophageal temperature management device
|
0.00%
0/86 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
0.00%
0/85 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Cardiac disorders
Cardiac arrhythmia
|
2.3%
2/86 • Number of events 2 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
1.2%
1/85 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/86 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
1.2%
1/85 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Injury, poisoning and procedural complications
Surgical bleeding, severe
|
3.5%
3/86 • Number of events 3 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
2.4%
2/85 • Number of events 2 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Hepatobiliary disorders
Postreperfusion syndrome
|
1.2%
1/86 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
2.4%
2/85 • Number of events 2 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Product Issues
Esophageal temperature management device problem
|
2.3%
2/86 • Number of events 2 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
1.2%
1/85 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Renal and urinary disorders
Electrolytes, overcorrection of hyponatremia
|
0.00%
0/86 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
1.2%
1/85 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Blood and lymphatic system disorders
Portal vein thrombus
|
0.00%
0/86 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
1.2%
1/85 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Injury, poisoning and procedural complications
Drug error
|
1.2%
1/86 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
0.00%
0/85 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Injury, poisoning and procedural complications
Traumatic central line insertion
|
1.2%
1/86 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
0.00%
0/85 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Cardiac disorders
Cardiovascular event, non-serious
|
1.2%
1/86 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
1.2%
1/85 • Number of events 1 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
|
Infections and infestations
Surgical site infection
|
0.00%
0/86 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
2.4%
2/85 • Number of events 2 • Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
|
Additional Information
Dr. Michael P. Bokoch, Principal Investigator
University of California, San Francisco
Phone: 415-476-8389
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place