Clinical trial NCT01211730: Study of Glycemic Control on Liver Transplantation Outcomes
Official title: Prospective, Randomized, Open-Label, Controlled Study to Evaluate the Safety and Efficacy of Intensive Glycemic Control on Outcomes Following Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Evidence of Liver Transplantation
Hyperglycemia
Rejection
Keywords: Liver
transplantation
Glucose
Hyperglycemia
Insulin
Rejection
Hypoglycemia
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many but not all studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. In this study, the investigators propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dL.

Detailed description: Many studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. However, some recent studies have not been able to reproduce these benefits and have raised the issue of adverse consequences of hypoglycemia associated with intensive therapy. Our own data show an association of increased graft rejection proportional to postoperative glucose levels in patients who have undergone a liver transplant. Preliminary data suggest that this may improved by better glycemic control using the Glucose Management Service here at Northwestern.

In this study, we propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dL. Postoperative glucose management with insulin will be supervised by the Glucose Management Service as is routine, with the only research aspect being the two different glucose targets and the outcome analysis with liver transplant rejection as the primary outcome and infections and hypoglycemia being the principle secondary outcomes.

Eligibility criteria: Inclusion Criteria:

1. Require Liver Transplantation
2. Age 18 - 80
3. Able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious.
4. Expected survival following transplantation for \> 1 year.
5. Glucose level over 180 mg/dL postoperatively

Exclusion Criteria:

1. Inability of patient or family member to give informed consent
2. Not expected to survive for \> 1 year following liver transplantation.
3. Previous liver transplantation
4. Acute liver failure
5. Living related donor

Primary outcomes:
measure: Rejection of Liver Transplant
timeFrame: within 1 year of transplantation
Secondary outcomes:
measure: Hypoglycemia
timeFrame: Within first 3 days following transplantation
measure: Infection Rates
timeFrame: Within 1 year following transplantation
measure: Rehospitalization Rates
timeFrame: Within 1 year following transplantation
measure: Overall Graft Survival at 1 Year
timeFrame: 1 year following transplantation
measure: Death Within 1 Year
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Mark E Molitch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: