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

This study has been completed.
Sponsor:
Information provided by:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00795015
First received: November 20, 2008
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes
 Drug: insulin regular IV infusion
Drug: IV insulin infusion
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With an Intravenous Insulin Infusion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Percent of blood glucose values in the target range 80-120 mg/dl [ Time Frame: first 200 hours post-op in the ICU ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent of patient days with a low blood glucose, defines as less than 60 mg/dl [ Time Frame: 200 hours while in ICU ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: April 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
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
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • s/p open heart or kidney or liver transplant surgery

Exclusion Criteria:

  • admission blood glucose less than 120 mg/dl
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795015

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: David Baldwin, MD Rush University Medical Center
  More Information

No publications provided

Responsible Party: David Baldwin MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00795015     History of Changes
Other Study ID Numbers: 06010501
Study First Received: November 20, 2008
Last Updated: March 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
postoperative blood glucose control
IV insulin infusion

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

ClinicalTrials.gov processed this record on June 18, 2013