Study of Glycemic Control on Liver Transplantation Outcomes

Phase 4

Completed

• Conditions: Rejection; Hyperglycemia; Evidence of Liver Transplantation
• Interventions: Drug: Insulin

• Registration Number: NCT01211730
• Lead Sponsor: Northwestern University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Primary Completion: 2015-12
• Study Completion: 2016-05
• Results First Submitted: 2016-09-12
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-31
• Last Update Submitted: 2016-10-31
• Results First Posted: 2016-12-23
• Last Update Posted: 2016-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
140 Group	Insulin	Insulin treatment to target blood glucose at 140 mg/dl
180 Group	Insulin	Insulin treatment to target blood glucose at 180 mg/dl

Primary Outcome Measures

Name	Time	Method
Rejection of Liver Transplant	within 1 year of transplantation	Liver transplant rejection determined by either biopsy or clinical criteria (\>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia	Within first 3 days following transplantation	Participants experiencing hypoglycemia (glucose \< 70 mg/dL) within the first 3- days following transplantation
Infection Rates	Within 1 year following transplantation
Rehospitalization Rates	Within 1 year following transplantation
Overall Graft Survival at 1 Year	1 year following transplantation
Death Within 1 Year	1 year	Death following liver transplant between 1 day and 1 year

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States