Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With IV Insulin
Study Details
Study Description
Brief Summary
The investigators are testing whether a written protocol or a computerized program can more effectively control blood glucose after surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Percent of blood glucose values in the target range 80-120 mg/dl [first 200 hours post-op in the ICU]
Secondary Outcome Measures
- Percent of patient days with a low blood glucose, defines as less than 60 mg/dl [200 hours while in ICU]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 06010501