Mild Hypothermia and Acute Kidney Injury in Liver Transplantation

Summary

Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies). Patients who experience AKI after liver transplantation have higher mortality, increased graft loss, longer hospital and intensive care unit stays, and more progression to chronic kidney disease compared with those who do not. In this study, half of the participants will have their body temperature cooled to slightly lower than normal (mild hypothermia) for a portion of the liver transplant operation, while the other half will have their body temperature maintained at normal. The study will evaluate if mild hypothermia protects from AKI during liver transplantation.

Conditions

• Cirrhosis
• End Stage Liver Disease
• Acute Kidney Injury
• Liver Transplant; Complications
• Chronic Kidney Diseases
• Hepatitis c
• Hepatitis B
• NASH - Nonalcoholic Steatohepatitis
• Alcoholic Cirrhosis
• Hepatocellular Carcinoma

Interventions

DEVICE

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.

OTHER

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.

OTHER

Normothermia

After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.

Sponsors & Collaborators

• University of Colorado, Denver

  collaborator OTHER

• The Methodist Hospital Research Institute

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Michael P Bokoch, MD, PhD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-07

Primary Completion

2023-08-17

Completion

2023-09-14

FDA Device

Yes

Countries

• United States

Study Locations