Trial Outcomes & Findings for Study of Glycemic Control on Liver Transplantation Outcomes (NCT NCT01211730)
NCT ID: NCT01211730
Last Updated: 2016-12-23
Results Overview
Liver transplant rejection determined by either biopsy or clinical criteria (\>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
164 participants
Primary outcome timeframe
within 1 year of transplantation
Results posted on
2016-12-23
Participant Flow
Patients were primarily recruited from Liver Transplant Clinic and the inpatient Liver Transplant service
Of 278 patients Consented, 46 died before transplant, 38 did not undergo transplant, 14 were delisted for transplant, and 16 did not enter the study for miscellaneous reasons.
Participant milestones
| Measure |
140 Group
Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
180 Group
Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
|
Overall Study
COMPLETED
|
82
|
82
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Glycemic Control on Liver Transplantation Outcomes
Baseline characteristics by cohort
| Measure |
140 Group
n=82 Participants
Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
180 Group
n=82 Participants
Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
56.9 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
57.5 years
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Gender
Female
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Gender
Male
|
53 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
57 participants
n=99 Participants
|
63 participants
n=107 Participants
|
120 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 participants
n=99 Participants
|
9 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
15 participants
n=99 Participants
|
7 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=99 Participants
|
82 participants
n=107 Participants
|
164 participants
n=206 Participants
|
|
body mass index
|
30.3 kg/m^2
STANDARD_DEVIATION 6.0 • n=99 Participants
|
30.0 kg/m^2
STANDARD_DEVIATION 6.6 • n=107 Participants
|
30.1 kg/m^2
STANDARD_DEVIATION 6.3 • n=206 Participants
|
|
Model for End-stage Liver DIsease (MELD) Score
|
27.3 units on a scale
STANDARD_DEVIATION 9.4 • n=99 Participants
|
28.2 units on a scale
STANDARD_DEVIATION 7.6 • n=107 Participants
|
27.8 units on a scale
STANDARD_DEVIATION 8.6 • n=206 Participants
|
|
Liver only Transplant
Liver Only
|
71 participants
n=99 Participants
|
68 participants
n=107 Participants
|
139 participants
n=206 Participants
|
|
Liver only Transplant
Liver Plus Kidney
|
11 participants
n=99 Participants
|
14 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Hepatitis C positive
Hepatitis C Positive
|
36 participants
n=99 Participants
|
32 participants
n=107 Participants
|
68 participants
n=206 Participants
|
|
Hepatitis C positive
Hepatitis C Negative
|
46 participants
n=99 Participants
|
50 participants
n=107 Participants
|
96 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: within 1 year of transplantationPopulation: Patients undergoing liver transplant
Liver transplant rejection determined by either biopsy or clinical criteria (\>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications
Outcome measures
| Measure |
140 Group
n=82 Participants
Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
180 Group
n=82 Participants
Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
|---|---|---|
|
Rejection of Liver Transplant
|
17 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Within first 3 days following transplantationPopulation: Patients having liver transplant
Participants experiencing hypoglycemia (glucose \< 70 mg/dL) within the first 3- days following transplantation
Outcome measures
| Measure |
140 Group
n=82 Participants
Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
180 Group
n=82 Participants
Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
|---|---|---|
|
Hypoglycemia
|
27 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Within 1 year following transplantationPopulation: patients having had liver transplants
Outcome measures
| Measure |
140 Group
n=82 Participants
Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
180 Group
n=82 Participants
Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
|---|---|---|
|
Infection Rates
|
35 participants
|
54 participants
|
SECONDARY outcome
Timeframe: Within 1 year following transplantationPopulation: patients undergoing liver transplant
Outcome measures
| Measure |
140 Group
n=82 Participants
Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
180 Group
n=82 Participants
Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
|---|---|---|
|
Rehospitalization Rates
|
48 participants
|
51 participants
|
SECONDARY outcome
Timeframe: 1 year following transplantationOutcome measures
| Measure |
140 Group
n=82 Participants
Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
180 Group
n=82 Participants
Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
|---|---|---|
|
Overall Graft Survival at 1 Year
|
77 participants
|
74 participants
|
SECONDARY outcome
Timeframe: 1 yearDeath following liver transplant between 1 day and 1 year
Outcome measures
| Measure |
140 Group
n=82 Participants
Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
180 Group
n=82 Participants
Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
|---|---|---|
|
Death Within 1 Year
|
5 participants
|
7 participants
|
Adverse Events
140 Group
Serious events: 53 serious events
Other events: 40 other events
Deaths: 0 deaths
180 Group
Serious events: 56 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
140 Group
n=82 participants at risk
Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
180 Group
n=82 participants at risk
Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
|---|---|---|
|
Hepatobiliary disorders
death within 1 year of transplant
|
6.1%
5/82 • Number of events 5 • 1st 30 days following transplant. This is the time of the insulin/glucose intervention
the major adverse event of the intervention was hypoglycemia, which is described in outcomes. There were no adverse sequelae of any of the hypoglycemic events
|
6.1%
5/82 • Number of events 5 • 1st 30 days following transplant. This is the time of the insulin/glucose intervention
the major adverse event of the intervention was hypoglycemia, which is described in outcomes. There were no adverse sequelae of any of the hypoglycemic events
|
|
Hepatobiliary disorders
Readmission within one year
|
58.5%
48/82 • Number of events 48 • 1st 30 days following transplant. This is the time of the insulin/glucose intervention
the major adverse event of the intervention was hypoglycemia, which is described in outcomes. There were no adverse sequelae of any of the hypoglycemic events
|
62.2%
51/82 • Number of events 51 • 1st 30 days following transplant. This is the time of the insulin/glucose intervention
the major adverse event of the intervention was hypoglycemia, which is described in outcomes. There were no adverse sequelae of any of the hypoglycemic events
|
Other adverse events
| Measure |
140 Group
n=82 participants at risk
Insulin treatment to target blood glucose at 140 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
180 Group
n=82 participants at risk
Insulin treatment to target blood glucose at 180 mg/dl
Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
|
|---|---|---|
|
Infections and infestations
Infections within one year of transplant
|
42.7%
35/82 • Number of events 35 • 1st 30 days following transplant. This is the time of the insulin/glucose intervention
the major adverse event of the intervention was hypoglycemia, which is described in outcomes. There were no adverse sequelae of any of the hypoglycemic events
|
65.9%
54/82 • Number of events 54 • 1st 30 days following transplant. This is the time of the insulin/glucose intervention
the major adverse event of the intervention was hypoglycemia, which is described in outcomes. There were no adverse sequelae of any of the hypoglycemic events
|
|
Hepatobiliary disorders
Liver Graft Failure within 1 year of transplant
|
6.1%
5/82 • Number of events 5 • 1st 30 days following transplant. This is the time of the insulin/glucose intervention
the major adverse event of the intervention was hypoglycemia, which is described in outcomes. There were no adverse sequelae of any of the hypoglycemic events
|
9.8%
8/82 • Number of events 8 • 1st 30 days following transplant. This is the time of the insulin/glucose intervention
the major adverse event of the intervention was hypoglycemia, which is described in outcomes. There were no adverse sequelae of any of the hypoglycemic events
|
Additional Information
Mark E. Molitch, M.D.
Northwestern University Feinberg School of Medicine
Phone: 312 503-4130
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place