Study of Glycemic Control on Liver Transplantation Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Mark Molitch, Northwestern University
ClinicalTrials.gov Identifier:
NCT01211730
First received: September 28, 2010
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Liver Transplantation
Hyperglycemia
Rejection
Drug: Insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Open-Label, Controlled Study to Evaluate the Safety and Efficacy of Intensive Glycemic Control on Outcomes Following Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Rejection of liver transplant [ Time Frame: within 1 year of transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hypoglycemia [ Time Frame: Within first 30 days following transplantation ] [ Designated as safety issue: Yes ]
  • Infection rates [ Time Frame: Within 1 year following transplantation ] [ Designated as safety issue: Yes ]
  • Rehospitalization rates [ Time Frame: Within 1 year following transplantation ] [ Designated as safety issue: No ]
  • Need for prolonged ventilation [ Time Frame: Within 1 year following transplantation ] [ Designated as safety issue: Yes ]
  • Overall graft survival at 1 year [ Time Frame: 1 year following transplantation ] [ Designated as safety issue: No ]
  • Development of Post-Transplant Diabetes [ Time Frame: Within 1 year following transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 164
Study Start Date: April 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 140 Group
Insulin treatment to target blood glucose at 140 mg/dl
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.
Other Names:
  • glargine insulin
  • aspart insulin
  • Lantus insulin
  • Novolog insulin
  • Detemir insulin
  • Levemir insulin
Active Comparator: 180 Group
Insulin treatment to target blood glucose at 180 mg/dl
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.
Other Names:
  • glargine insulin
  • aspart insulin
  • Lantus insulin
  • Novolog insulin
  • Detemir insulin
  • Levemir insulin

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211730

Contacts
Contact: Mark E Molitch, M.D. 312 503-4130 molitch@northwestern.edu
Contact: Amisha Wallia, M.D. 312 503-2756 amisha.wallia@gmail.com

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Mark E Molitch, M.D.         
Sub-Investigator: Amisha Wallia, M.D.         
Sub-Investigator: Josh Levitsky, M.D.         
Sub-Investigator: Michael Abecassis, M.D.         
Sub-Investigator: Grazia Aleppo, M.D.         
Sub-Investigator: Kathleen Schmidt, MSN, APRN-BC         
Sub-Investigator: Diana Johnson, MSN, APRN-BC         
Sub-Investigator: Donna Kamuda, MSN, APRN-BC         
Sub-Investigator: Erica Tayban, APRN-BC         
Sub-Investigator: Maggie Steingraber-Pharr, APRN-BC         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Mark E Molitch, M.D. Northwestern University Feinberg School of Medicine
  More Information

No publications provided

Responsible Party: Mark Molitch, Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01211730     History of Changes
Other Study ID Numbers: STU00005806
Study First Received: September 28, 2010
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Liver
transplantation
Glucose
Hyperglycemia
Insulin
Rejection
Hypoglycemia

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014