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Completed

NCT Number: NCT01211730

Study of Glycemic Control on Liver Transplantation Outcomes

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Require Liver Transplantation
  • Age 18 - 80
  • Able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious.
  • Expected survival following transplantation for > 1 year.
  • Glucose level over 180 mg/dL postoperatively

Exclusion criteria

  • Inability of patient or family member to give informed consent
  • Not expected to survive for > 1 year following liver transplantation.
  • Previous liver transplantation
  • Acute liver failure
  • Living related donor

Treatment and study plan

Insulin

Drug

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

Primary outcomes

  1. 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 outcomes

  1. Hypoglycemia

    Time frame: Within first 3 days following transplantation

    Participants experiencing hypoglycemia (glucose < 70 mg/dL) within the first 3- days following transplantation

  2. Infection Rates

    Time frame: Within 1 year following transplantation

  3. Rehospitalization Rates

    Time frame: Within 1 year following transplantation

  4. Overall Graft Survival at 1 Year

    Time frame: 1 year following transplantation

  5. Death Within 1 Year

    Time frame: 1 year

    Death following liver transplant between 1 day and 1 year

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2016
First posted
Sep 29, 2010
Registry last updated
Dec 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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