Intraoperative Glucose Control in Liver Transplant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shawn J. Pelletier, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00780026
First received: October 22, 2008
Last updated: October 18, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Liver Transplant
Procedure: insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect Of Intraoperative Strict Glycemic Control During Liver Transplantation On Postoperative Morbidity And Mortality

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Infection rates and one year survival post transplant [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospital length of stay [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Postoperative requirements for blood transfusion within 3 days in the ICU [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Need for and duration of hemodialysis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of biliary complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of venous thromboembolic events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: July 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
strict glycemic control (80 to 110 mg/dl)
Procedure: insulin
bolus or infusion 80 to 110 mg/dl
No Intervention: 2
standard of care insulin dosing

Detailed Description:

Approximately 2.1 million patients in the United States acquire infections during medical care every year. For example, 9%-30% patients who undergo surgery acquire nosocomial infections, which increase mortality and morbidity over that expected normally expected and increase the cost of care by several billion dollars. Studies have shown that controlling high blood glucose levels dramatically improves the recovery of critically ill patients after surgery, most notably decreasing the risk of infection. The advantage of strict glycemic control in the critically ill patient is now well accepted, and the Institute for Healthcare Improvement and Surviving Sepsis Campaign set glycemic control as part of the post-operative sepsis management bundle.

Few studies have investigated the role of strict glycemic control during surgery itself. Liver transplantation is a good model for studying glucose control as hyperglycemia almost always occurs and the incidence of infection is higher than with other surgical procedures. We performed a retrospective review of 184 consecutive adult liver recipients in which intra-operative blood glucose levels were measured and treated with insulin. Recipients with strict glycemic control were compared to those with poor control for differences in donor and recipient demographics, intra-operative blood glucose concentrations, intra-operative insulin administered, immunosuppression, post-operative complications, and mortality. Poor glycemic control was associated with a significantly increased rate of infection during the first 30 days post-operatively (48% vs. 33%, P=0.05) and 1-year mortality was significantly increased for those recipients with poor intra-operative glucose control (21.9% vs. 8.8%; P = 0.05). These data along with the post-operative studies, suggest that the post-transplant mortality rate may potentially be decreased by nearly 50% at 1 year and underscore the need for this to be confirmed in a prospective trial.

The goal of this study is to prospectively evaluate the outcomes of liver transplant recipients to either strict glucose control (goal of 80-110 mg/dl) or the current standard of care (goal of between 180 and 200 mg/dl). The specific aim of this study is to determine if strict intra-operative blood glucose control, improves 1-year recipient survival and decreases surgical complications, including infections, following liver transplantation. The rates of infection at 30 days after surgery and health at one year post- surgery will be compared. The frequency of other common post-operation complications will also be studied. The proposed study has the potential to have an impact on the intra-operative management of all liver transplant recipients.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 an ABO incompatible liver
  • 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 hCG laboratory test (> 5 mIU/ml)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780026

Contacts
Contact: Mary J Maliarik, PhD 734-615-8627 marymali@umich.edu
Contact: Darlene McLean, BA, RN 734-615-3822 darkons@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Sub-Investigator: Theodore Welling, MD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Shawn Pelletier, MD Universitry of Michigan
  More Information

No publications provided

Responsible Party: Shawn J. Pelletier, MD, Associate Professor of Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT00780026     History of Changes
Other Study ID Numbers: HUM00016106
Study First Received: October 22, 2008
Last Updated: October 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
liver
transplant
blood sugar

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014