Phase 4 N=100 Randomized Supportive Care

Intraoperative Glucose Control in Liver Transplant

Liver Transplant

Bottom Line

View on ClinicalTrials.gov: NCT00780026 ↗

Enrolled (actual)

100

Serious AEs

27.0%

Results posted

Dec 2017

Primary outcome: Primary: Infection Rates — 27; 26; 11; 7 Participants — p=0.841

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: insulin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Infection Rates	27; 26; 11; 7; 9; 7	0.841
PRIMARY Number of Participants With One Year Survival Post Transplant	44; 44	0.999
SECONDARY Hospital Length of Stay	12.5; 11	0.384
SECONDARY Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU	0; 0	—
SECONDARY Number of Participants With a Need for Hemodialysis	6; 9	0.401
SECONDARY Number of Participants With Biliary Complications	14; 15; 13; 20	0.826
SECONDARY Number of Participants With Venous Thrombotic Complications	3; 3	0.999

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, 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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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)

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Data sourced from ClinicalTrials.gov (NCT00780026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.