Status:
COMPLETED
Intraoperative Glucose Control in Liver Transplant
Lead Sponsor:
University of Michigan
Conditions:
Liver Transplant
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
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, pros...
Detailed Description
Approximately 2.1 million patients in the United States acquire infections during medical care every year. For example, 9%-30% patients who undergo surgery acquire nosocomial infections, which increas...
Eligibility Criteria
Inclusion
- Male or female patients ≥ 18 years old undergoing liver transplantation
- Patients willing and capable of giving written informed consent for study participation
Exclusion
- 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)
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00780026
Start Date
July 1 2008
End Date
September 1 2009
Last Update
January 15 2019
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109