Study of Glycemic Control on Liver Transplantation Outcomes

Northwestern University

Status and phase: Completed; Phase 4

Conditions: Evidence of Liver Transplantation; Hyperglycemia; Rejection

Treatments: Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT01211730

STU00005806

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

140 Group

Active Comparator group

Description:

Insulin treatment to target blood glucose at 140 mg/dl

Treatment:

Drug: Insulin

180 Group

Active Comparator group

Description:

Insulin treatment to target blood glucose at 180 mg/dl

Treatment:

Drug: Insulin