Study of Glycemic Control on Liver Transplantation Outcomes

Hyperglycemia Clinical Trial

Official title:

Prospective, Randomized, Open-Label, Controlled Study to Evaluate the Safety and Efficacy of Intensive Glycemic Control on Outcomes Following Liver Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01211730
• Other study ID #: STU00005806
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: October 5, 2015
• Start date: April 2009
• Est. completion date: March 2016

Study information

• Verified date: October 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 164
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Evidence of Liver Transplantation
• Hyperglycemia
• Rejection

Intervention

Drug:
• Insulin
Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rejection of liver transplant		within 1 year of transplantation	Yes
Secondary	Hypoglycemia		Within first 30 days following transplantation	Yes
Secondary	Infection rates		Within 1 year following transplantation	Yes
Secondary	Rehospitalization rates		Within 1 year following transplantation	No
Secondary	Need for prolonged ventilation		Within 1 year following transplantation	Yes
Secondary	Overall graft survival at 1 year		1 year following transplantation	No
Secondary	Development of Post-Transplant Diabetes		Within 1 year following transplantation	No