Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With IV Insulin

Overview

The investigators are testing whether a written protocol or a computerized program can more effectively control blood glucose after surgery.

Full Title of Study: “Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With an Intravenous Insulin Infusion”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2006

Detailed Description

In 2002 we adapted the protocol described by Van den Berghe et al. for use in our own surgical intensive care unit (SICU) with a target blood glucose range from 80 to 120mg/dL. After five years of implementation, we were able to achieve a mean BG of 117 mg/dL in the SICU. 2% of glucose values were <60 mg/dL in the SICU. Given the concern of safety while optimizing glycemic control, we investigated the etiologies for these hypoglycemic episodes and have found two frequent risk factors; the failure to consistently measure blood glucose every hour and in patients with end stage renal failure. We will investigate whether a computer-based algorithm for the titration of IV insulin will translate to better clinical outcomes and less hypoglycemia. Therefore, we will conduct a prospective randomized trial comparing the Glucommander, a computer-based algorithm with our Van den Berghe protocol for titration of IV insulin in patients after cardiovascular or transplant surgery. This computer based algorithm was invented in 1984 in Atlanta by Dr. Davidson and Dr. Steed who have used it in a variety of applications of IV insulin.

Interventions

  • Drug: insulin regular IV infusion
    • IV insulin was administered by continuous infusion and the rate changed every hour according to the blood glucose level as determined by each of the protocols being compared
  • Drug: IV insulin infusion
    • IV insulin was administered by continuous infusion and the rate changed every hour according to the blood glucose level as determined by each of the protocols being compared

Arms, Groups and Cohorts

  • Active Comparator: leuven
    • these patients had their IV insulin controlled by using the protocol adapted from van den Berghe et al. University of Leuven, Belgium, NEJM Nov. 2001
  • Active Comparator: glucommander
    • these subjects had IV insulin controlled by a computer program called the glucommander described by Davidson, P et al Diabetes Care Oct. 2005

Clinical Trial Outcome Measures

Primary Measures

  • Percent of blood glucose values in the target range 80-120 mg/dl
    • Time Frame: first 200 hours post-op in the ICU

Secondary Measures

  • Percent of patient days with a low blood glucose, defines as less than 60 mg/dl
    • Time Frame: 200 hours while in ICU

Participating in This Clinical Trial

Inclusion Criteria

  • s/p open heart or kidney or liver transplant surgery Exclusion Criteria:

  • admission blood glucose less than 120 mg/dl

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rush University Medical Center
  • Provider of Information About this Clinical Study
    • David Baldwin MD, Rush University Medical Center
  • Overall Official(s)
    • David Baldwin, MD, Principal Investigator, Rush University Medical Center

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