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=5 Participants	56.9 years STANDARD_DEVIATION 7.6 • n=7 Participants	57.5 years STANDARD_DEVIATION 7.8 • n=5 Participants
Gender Female	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Gender Male	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	57 participants n=5 Participants	63 participants n=7 Participants	120 participants n=5 Participants
Race/Ethnicity, Customized Black	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	15 participants n=5 Participants	7 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Unknown	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants	82 participants n=7 Participants	164 participants n=5 Participants
body mass index	30.3 kg/m^2 STANDARD_DEVIATION 6.0 • n=5 Participants	30.0 kg/m^2 STANDARD_DEVIATION 6.6 • n=7 Participants	30.1 kg/m^2 STANDARD_DEVIATION 6.3 • n=5 Participants
Model for End-stage Liver DIsease (MELD) Score	27.3 units on a scale STANDARD_DEVIATION 9.4 • n=5 Participants	28.2 units on a scale STANDARD_DEVIATION 7.6 • n=7 Participants	27.8 units on a scale STANDARD_DEVIATION 8.6 • n=5 Participants
Liver only Transplant Liver Only	71 participants n=5 Participants	68 participants n=7 Participants	139 participants n=5 Participants
Liver only Transplant Liver Plus Kidney	11 participants n=5 Participants	14 participants n=7 Participants	25 participants n=5 Participants
Hepatitis C positive Hepatitis C Positive	36 participants n=5 Participants	32 participants n=7 Participants	68 participants n=5 Participants
Hepatitis C positive Hepatitis C Negative	46 participants n=5 Participants	50 participants n=7 Participants	96 participants n=5 Participants

PRIMARY outcome

Timeframe: within 1 year of transplantation

Population: 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 transplantation

Population: 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 transplantation

Population: 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 transplantation

Population: 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 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.
Overall Graft Survival at 1 Year	77 participants	74 participants

SECONDARY outcome

Timeframe: 1 year

Death 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: molitch@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place