Intensive Glycemic Management and Outcomes Following Liver Transplantation

Not Applicable

Completed

• Conditions: Hospital Hyperglycemia; Post-transplant Hyperglycemia
• Interventions: Other: Intensive glycemic management; Other: Conventional management

• Registration Number: NCT01432093
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-12
• Study Start: 2011-10
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

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

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Exclusion Criteria

• Unable to grant informed consent or comply with study procedure
• Allergic to any of the excipients in insulin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive glycemic management	Intensive glycemic management	Multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards.
Conventional management	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.

Primary Outcome Measures

Name	Time	Method
Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation.	90 days 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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States