Blood Glucose Control With A Software-Algorithm In Intensive Care Unit (ICU) Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-02-28

Brief Summary

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Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Recently, large randomized controlled trials have demonstrated that tight glycaemic control (TGC) reduces morbidity and mortality in this population. Based on this emerging evidence intensive insulin therapy is currently finding its way into the critical care practice.

In the meantime numerous insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented. Recent reviews comparing different types of protocols describe widely ranging practice and difficulties in achieving TGC despite extensive efforts of the intensive care unit (ICU) staff. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. The primary objective of the current study is to investigate the performance (efficacy) of a control algorithm for glycaemic control in ICU patients for the whole length of ICU stay.

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Detailed Description

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Conditions

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Critical Illness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

improved model predictive control algorithm (eMPC) for glycaemic control in ICU patients

Group Type EXPERIMENTAL

enhanced model predictive control algorithm (eMPC)

Intervention Type OTHER

eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control

Interventions

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enhanced model predictive control algorithm (eMPC)

eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age: \> 18 years of age
* Stay in the ICU expected to be \> 120 h
* Blood glucose \> 110 mg/dl or patient on insulin treatment

Exclusion Criteria

* Patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
* Known or suspected allergy to insulin
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
* Moribund patients likely to die within 24 hours

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No