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

Phase 4

Completed

• Conditions: Diabetes
• Interventions: Drug: insulin regular IV infusion; Drug: IV insulin infusion

• Registration Number: NCT00795015
• Lead Sponsor: Rush University Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2006-04
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-15
• Last Update Posted: 2011-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

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

Exclusion Criteria

• admission blood glucose less than 120 mg/dl

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
leuven	insulin regular IV infusion	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
leuven	IV insulin infusion	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
glucommander	insulin regular IV infusion	these subjects had IV insulin controlled by a computer program called the glucommander described by Davidson, P et al Diabetes Care Oct. 2005
glucommander	IV insulin infusion	these subjects had IV insulin controlled by a computer program called the glucommander described by Davidson, P et al Diabetes Care Oct. 2005

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States