Phase 4
Completed N=100
Intraoperative Glucose Control in Liver Transplant
Source: ClinicalTrials.gov NCT00780026 ↗Enrolled (actual)
100
Serious AEs
27.0%
Results posted
Dec 2017
Primary outcomePrimary: Infection Rates — 27; 26; 11; 7 Participants — p=0.841
◆ Published Evidence
Emerging
14citations · ~2 / year
Intraoperative glycemic control in patients undergoing Orthotopic liver transplant: a single center prospective randomized study.
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.
Linked Publications
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Intraoperative glycemic control in patients undergoing Orthotopic liver transplant: a single center prospective randomized study.
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 |
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)
Data sourced from ClinicalTrials.gov (NCT00780026) and the linked publication. 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. Informational only — not medical advice.