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

November 20, 2008
March 15, 2011
April 2006
December 2006   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00795015 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With IV Insulin
Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With an Intravenous Insulin Infusion

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes
  • 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: 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
    Interventions:
    • Drug: insulin regular IV infusion
    • Drug: IV insulin infusion
  • 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
    Interventions:
    • Drug: insulin regular IV infusion
    • Drug: IV insulin infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • admission blood glucose less than 120 mg/dl
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00795015
06010501
No
David Baldwin MD, Rush University Medical Center
Rush University Medical Center
Not Provided
Principal Investigator: David Baldwin, MD Rush University Medical Center
Rush University Medical Center
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP