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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: insulin regular IV infusion; Drug: IV insulin infusion

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• admission blood glucose less than 120 mg/dl

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: David Baldwin, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: November 20, 2008
• First Submitted That Met QC Criteria: November 20, 2008
• First Posted (Estimate): November 21, 2008

Study Record Updates

• Last Update Posted (Estimate): March 16, 2011
• Last Update Submitted That Met QC Criteria: March 15, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: postoperative blood glucose control; IV insulin infusion
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 06010501