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Completed

NCT Number: NCT00795015

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

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • admission blood glucose less than 120 mg/dl

Treatment and study plan

insulin regular IV infusion

Drug

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

IV insulin infusion

Drug

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

Primary outcomes

  1. Percent of blood glucose values in the target range 80-120 mg/dl

    Time frame: first 200 hours post-op in the ICU

Secondary outcomes

  1. Percent of patient days with a low blood glucose, defines as less than 60 mg/dl

    Time frame: 200 hours while in ICU

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With an Intravenous Insulin Infusion

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Nov 21, 2008
Registry last updated
Mar 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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