Intraoperative Glucose Control in Liver Transplant

Completed · Phase 4

Conditions studied: Liver Transplant

In brief

The goal of the proposed study is to evaluate the effectiveness of intraoperative, strict glycemic control to improve survival and infection rates following liver transplantation in a randomized, prospective trial.Primary objective: To determine if strict intraoperative blood glucose control, when compared to standard intraoperative glycemic control, improves 1-year recipient survival and decreases surgical complications, including infections, following liver transplantation.

Key facts

Study ID

NCT00780026

Run by

University of Michigan

People needed

100

Starts

2008-07-01

Expected to finish

2009-09-01

Last updated by the study team

2019-01-15

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients ≥ 18 years old undergoing liver transplantation
• Patients willing and capable of giving written informed consent for study participation

You may not qualify if…

• Multi-organ transplant recipients
• Patients receiving a liver incompatible with A, B or O blood types
• HIV infected patients
• Recipients of an organ from an HIV+ donor
• Patients with severe coexisting disease or presenting with any unstable medical condition which could affect the study objectives
• Patients with a co-existing alcoholic disease who have not been abstinent for at least 6 month immediately prior to transplantation and are not expected to be able to remain abstinent after transplantation
• Patients who are unlikely to comply with the study requirements or unable to give informed consent
• Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer or if such therapy is to be instituted posttransplantation
• Patients transplanted for hepatocellular carcinoma exceeding 3 nodules or with nodule diameter larger than 5 cm
• History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadatropin (hCG) laboratory test (> 5 milli-International units (mIU/ml)

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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