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Intensive Glycemic Management and Outcomes Following Liver Transplantation

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Gunjan Gandhi, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01432093
First received: September 7, 2011
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

Most people develop high blood sugars following liver transplant that requires treatment with insulin in the hospital, even if they don't have diabetes, due to stress and use of steroid medications. High blood sugar levels can be treated with a hormone that the body makes called insulin. This study is being done to determine if maintaining normal blood sugar levels after transplant for as long as needed while in the hospital results in a lesser incidence of death, infections, transplanted liver rejection or failure or need for rehospitalization within 90 days after transplant.


Condition Intervention
Hospital Hyperglycemia
Post-transplant Hyperglycemia
 Other: Intensive glycemic management
Other: Conventional management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Glycemic Management and Outcomes Following Liver Transplantation: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation. [ Time Frame: 90 days following liver transplantation. ] [ Designated as safety issue: No ]
    The primary outcome is a 90 day composite of mortality by any cause, graft failure, rejection, infections, and rehospitalization following liver transplantation.


Secondary Outcome Measures:
  • Compare length of stay in the ICU and hospital in the two study groups. [ Time Frame: 90 days following liver transplantation. ] [ Designated as safety issue: No ]
  • Compare the incidence of hypoglycemia in the ICU and hospital in the two study groups. [ Time Frame: 90 days following liver transplantation. ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intensive glycemic management
Multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards.
 Other: Intensive glycemic management
Intravenous insulin infusion, strict dietary intervention, carbohydrate matched subcutaneous insulin therapy. This is a multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards.
Active Comparator: Conventional management
Conventional treatment to control hyperglycemia with a target glucose goal of 120 to 150 mg/dL in the ICU and 140 to 180 mg/dL on the hospital floors.
 Other: Conventional management
Conventional treatment to control hyperglycemia with a target glucose goal of 120 to 150 mg/dL in the ICU and 140 to 180 mg/dL on the hospital floors.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age and older
  • Undergoing liver transplant or combined liver-kidney transplant

Exclusion Criteria:

  • Unable to grant informed consent or comply with study procedure
  • Allergic to any of the excipients in insulin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432093

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Gunjan Y. Gandhi, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Gunjan Gandhi, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01432093     History of Changes
Other Study ID Numbers: 11-002918
Study First Received: September 7, 2011
Last Updated: November 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
liver transplant
high blood sugars
hospital hyperglycemia
 post-transplant hyperglycemia
post liver transplant
post liver-kidney transplant

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013