Phase 4
N=164
Study of Glycemic Control on Liver Transplantation Outcomes
Evidence of Liver Transplantation · Hyperglycemia · Rejection
Bottom Line
View on ClinicalTrials.gov: NCT01211730 ↗Enrolled (actual)
164
Serious AEs
66.5%
Results posted
Dec 2016
Primary outcome: Primary: Rejection of Liver Transplant — 17; 20 participants — p=0.709
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rejection of Liver Transplant |
17; 20 | 0.709 |
| SECONDARY Hypoglycemia |
27; 10 | 0.003 sig |
| SECONDARY Infection Rates |
35; 54 | 0.0046 sig |
| SECONDARY Rehospitalization Rates |
48; 51 | 0.75 |
| SECONDARY Overall Graft Survival at 1 Year |
77; 74 | 0.56 |
| SECONDARY Death Within 1 Year |
5; 7 | 0.77 |
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.
Eligibility Criteria
Inclusion Criteria
- Require Liver Transplantation
- Age 18 - 80
- Able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious.
- Expected survival following transplantation for > 1 year.
- Glucose level over 180 mg/dL postoperatively
Exclusion Criteria
- Inability of patient or family member to give informed consent
- Not expected to survive for > 1 year following liver transplantation.
- Previous liver transplantation
- Acute liver failure
- Living related donor
Data sourced from ClinicalTrials.gov (NCT01211730). 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.