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Study of Glycemic Control on Liver Transplantation Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211730
First Posted: September 29, 2010
Last Update Posted: December 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark Molitch, Northwestern University
  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
Evidence of Liver Transplantation Hyperglycemia Rejection Drug: Insulin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Mark Molitch, Northwestern University:

Primary Outcome Measures:
  • Rejection of Liver Transplant [ Time Frame: 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:
  • Hypoglycemia [ Time Frame: Within first 3 days following transplantation ]
    Participants experiencing hypoglycemia (glucose < 70 mg/dL) within the first 3- days following transplantation

  • Infection Rates [ Time Frame: Within 1 year following transplantation ]
  • Rehospitalization Rates [ Time Frame: Within 1 year following transplantation ]
  • Overall Graft Survival at 1 Year [ Time Frame: 1 year following transplantation ]
  • Death Within 1 Year [ Time Frame: 1 year ]
    Death following liver transplant between 1 day and 1 year


Enrollment: 164
Study Start Date: April 2009
Study Completion Date: May 2016
Primary Completion Date: December 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211730


Locations
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Mark E Molitch, M.D. Northwestern University Feinberg School of Medicine
  More Information

Responsible Party: Mark Molitch, Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01211730     History of Changes
Other Study ID Numbers: STU00005806
First Submitted: September 28, 2010
First Posted: September 29, 2010
Results First Submitted: September 12, 2016
Results First Posted: December 23, 2016
Last Update Posted: December 23, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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