ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoperative Glucose Control in Liver Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00780026
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Shawn J. Pelletier, MD, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Liver Transplant Drug: insulin Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect Of Intraoperative Strict Glycemic Control During Liver Transplantation On Postoperative Morbidity And Mortality
Study Start Date : July 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Strict Glycemic Control
strict glycemic control (80 to 110 mg/dl)
Drug: insulin
bolus or infusion 80 to 110 mg/dl
No Intervention: Standard of Care Control
standard of care insulin dosing



Primary Outcome Measures :
  1. Infection Rates [ Time Frame: 30 days ]
    Number of participants who sustained an infection after surgery

  2. One Year Survival Post Transplant [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: 12 months ]
  2. Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU [ Time Frame: 12 months ]
    Requirements for blood transfusion counted as a binary variable yes/no per participant

  3. Need for Hemodialysis [ Time Frame: 12 months post surgery ]
    Number of people who had renal failure in the year following liver transplant and needing hemodialysis to support it;

  4. Incidence of Biliary Complications [ Time Frame: 12 months ]
    Number of participants who experienced bile leak or biliary Stricture

  5. Incidence of Venous Thrombotic Complications [ Time Frame: 12 months ]
    Number of participants who were diagnosed with portal vein thrombosis post surgery



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780026


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Shawn Pelletier, MD Universitry of Michigan

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
First Posted: October 24, 2008    Key Record Dates
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Shawn J. Pelletier, MD, University of Michigan:
liver
transplant
blood sugar

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