Computerized Glucose Control in Critically Ill Patients

Summary

The aim of the study is to determine whether the use of the CGAOtm software is associated with a decrease in 90-day mortality when compared with the use of standard care methods for glucose control with target blood glucose levels inferior to 180 mg/dl. The CGAOtm software is designed to assist physicians and nurses in achieving tight glucose control (defined by a target for blood glucose levels between 80 and 110 mg/dl) in critically ill patients.

Conditions

• Hyperglycemia
• Critical Illness

Interventions

DEVICE

CGAO-based Glucose Control

Use of a clinical computerized decision-support system named CGAOtm designed to achieve tight glucose control in various ICU settings, and fine-tuned to reduce glucose variability without increasing the incidence of severe hypoglycemia or nurse workload. CGAOtm is based on explicit replicable recommendations following each blood glucose measurement for insulin rates and time to next measurement, and reminders, alerts, graphic tools, trends, and individual on-line data aimed at increasing confidence of the nursing staff in the computer protocol and giving care staff a method for controlling the process during the whole ICU stay, according to a "human-in-the-loop" approach. The algorithm used in the CGAOtm software for the calculation of the recommended insulin rates derived from a PID (Proportional-integral-derivative) controller, a generic control loop feedback mechanism widely used in industrial control.

DEVICE

Standard-Care Glucose Control

Patients in the control group will receive conventional insulin therapy using the "usual care" protocol of each participating centre (already used in the centre before the beginning of the trial and targeting blood glucose levels inferior to 180 mg/dl).

Sponsors & Collaborators

• Société Française d'Anesthésie et de Réanimation

  collaborator OTHER

• Baxter Healthcare Corporation

  collaborator INDUSTRY

• Centre Hospitalier of Chartres

  lead OTHER

Principal Investigators

• Pierre Kalfon, MD · Centre Hospitalier de Chartres

• Bruno Riou, MD PhD · G.H.U. Est, C.H.U. Pitié-Salpétriêre

• Djillali Annane, MD PhD · G.H.U. Ouest, Hôpital Raymond Poincaré

• Jean Chastre, MD PhD · G.H.U. Est, Pitié-Salpétriêre

• Pierre-François Dequin, MD PhD · CHRU TOURS

• Hervé Dupont, MD PhD · CHRU Amiens

• Carole Ichai, MD PhD · CHRU de Nice

• Yannick Malledant, MD PhD · CHRU Rennes

• Philippe Montravers, MD PhD · G.H.U. Nord Bichat-Claude Bernard

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2012-12-31

Completion

2013-04-30

Countries

• France

Study Locations