Intensive Glycemic Management and Outcomes Following Liver Transplantation

NCT01432093 | Completed DMC

• 1 other identifier: 11-002918
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospital Hyperglycemia; Post-transplant Hyperglycemia

Keywords

liver transplant; high blood sugars; hospital hyperglycemia; post-transplant hyperglycemia; post liver transplant; post liver-kidney transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (2)

Intensive glycemic management

ACTIVE COMPARATOR

Multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards.

Other: Intensive glycemic management

Conventional management

ACTIVE COMPARATOR

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

Interventions

Intensive glycemic management OTHER

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.

Intensive glycemic management

Conventional management OTHER

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.

Conventional management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Study Officials

• Gunjan Y. Gandhi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 12, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

US (1)