Intraoperative Glucose Control in Liver Transplant

NCT00780026 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HUM00016106
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Transplant

Keywords

liver; transplant; blood sugar

Outcome Measures

Primary Outcomes (2)

• Infection Rates

  Number of participants who sustained an infection after surgery

  30 days

• Number of Participants With One Year Survival Post Transplant

  12 months

Secondary Outcomes (5)

• Hospital Length of Stay

  12 months

• Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU

  12 months

• Number of Participants With a Need for Hemodialysis

  12 months post surgery

• Number of Participants With Biliary Complications

  12 months

• Number of Participants With Venous Thrombotic Complications

  12 months

Study Arms (2)

Strict Glycemic Control

EXPERIMENTAL

strict glycemic control (80 to 110 mg/dl)

Drug: insulin

Standard of Care Control

NO INTERVENTION

standard of care insulin dosing

Interventions

insulin DRUG

bolus or infusion 80 to 110 mg/dl

Strict Glycemic Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Kumar SS, Pelletier SJ, Shanks A, Thompson A, Sonnenday CJ, Picton P. Intraoperative glycemic control in patients undergoing Orthotopic liver transplant: a single center prospective randomized study. BMC Anesthesiol. 2020 Jan 4;20(1):3. doi: 10.1186/s12871-019-0918-0.

  PMID: 31901245 DERIVED

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Subramanian Sathishkumar
• Organization: University of Michigan

ssatish@med.umich.edu

Study Officials

• Shawn Pelletier, MD

  Universitry of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 24, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 15, 2019
• Results First Posted: December 6, 2017

Record last verified: 2018-12

Locations

US (1)