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

Rush

Status and phase: Completed; Phase 4

Conditions: Diabetes

Treatments: Drug: insulin regular IV infusion; Drug: IV insulin infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00795015

06010501

Details and patient eligibility

About

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

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• admission blood glucose less than 120 mg/dl

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

leuven

Active Comparator group

Description:

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

Treatment:

Drug: insulin regular IV infusion

Drug: IV insulin infusion

glucommander

Active Comparator group

Description:

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

Treatment:

Drug: insulin regular IV infusion

Drug: IV insulin infusion