CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 164 enrolled
Drug / intervention
Insulindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01211730
NCT01211730Phase 4Completed
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Prospective, Randomized, Open-Label, Controlled Study to Evaluate the Safety and Efficacy of Intensive Glycemic Control on Outcomes Following Liver Transplantation

Northwestern University·interventional·Posted Sep 29, 2010·Updated Dec 23, 2016

In Brief

A Phase 4 clinical trial evaluating Insulin for Evidence of Liver Transplantation and 2 related conditions. Completed, enrolled 164 participants across 1 site.

Detailed Summary

Many but not all studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. In this study, the investigators propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEvidence of Liver Transplantation, Hyperglycemia, Rejection
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 29, 2010
Enrollment StartApr 1, 2009
Primary CompletionDec 1, 2015
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 15.8 years ago

Interventions

Insulindrug

Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.