Intensive Glycemic Management and Outcomes Following Liver Transplantation

Intensive Glycemic Management and Outcomes Following Liver Transplantation: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Hospital Hyperglycemia; Post-transplant Hyperglycemia
• Intervention / Treatment: Other: Intensive glycemic management; Other: Conventional management

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation.	The primary outcome is a 90 day composite of mortality by any cause, graft failure, rejection, infections, and rehospitalization following liver transplantation.	90 days following liver transplantation.

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare length of stay in the ICU and hospital in the two study groups.	90 days following liver transplantation.
Compare the incidence of hypoglycemia in the ICU and hospital in the two study groups.	90 days following liver transplantation.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Gunjan Y. Gandhi, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: September 7, 2011
• First Submitted That Met QC Criteria: September 8, 2011
• First Posted (Estimate): September 12, 2011

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 11, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: liver transplant; high blood sugars; hospital hyperglycemia; post-transplant hyperglycemia; post liver transplant; post liver-kidney transplant
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 11-002918