drugset / Trial / NCT00780026

Intraoperative Glucose Control in Liver Transplant

NCT00780026 ↗

Phase 4 Completed 100 enrolled University of Michigan
RandomizedParallel-groupOpen-labelSupportive care

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.

Timeline

Start
2008-07
Primary completion
2009-09
Completion
2009-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Strict Glycemic Control vs Standard of Care Control; p = 0.999; Fisher Exact NCT00780026 ↗

paper There was no statistically significant difference in patient survival between conventional and strict control respectively;1 year, 88% vs 88% (p-0.99) PMID 31901245 ↗

registry analysis (superiority or other test); Strict Glycemic Control vs Standard of Care Control; p = 0.841; Chi-squared; note: P value for Bacterial infection NCT00780026 ↗

registry analysis (superiority or other test); Strict Glycemic Control vs Standard of Care Control; p = 0.298; Chi-squared; note: P-value for fungal infection NCT00780026 ↗

registry analysis (superiority or other test); Strict Glycemic Control vs Standard of Care Control; p = 0.585; Chi-squared; note: P value for transplant incision wound NCT00780026 ↗

registry analysis (superiority or other test); Strict Glycemic Control vs Standard of Care Control; p = 0.505; Chi-squared; note: P value for viral infection NCT00780026 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic — —

Indications

No indication recorded.