Tight computerized versus conventional glucose control in the ICU: a randomized controlled trial
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The blood glucose target range and optimal method to reach this range remain a matter of debate in the intensive care unit (ICU). A computer decision support system (CDSS) might improve the outcome of ICU patients through facilitation of a tighter blood glucose control.
We conducted a multi-center randomized trial in 34 French ICU. Adult patients expected to require treatment in the ICU for at least 3 days were randomly assigned without blinding to undergo tight computerized glucose control with the CDSS (TGC) or conventional glucose control (CGC), with blood glucose targets of 4.4–6.1 and <10.0 mmol/L, respectively. The primary outcome was all-cause death within 90 days after ICU admission.
Of the 2,684 patients who underwent randomization to the TGC and CGC treatment groups, primary outcome was available for 1,335 and 1,311 patients, respectively. The baseline characteristics of these treatment groups were similar in terms of age (61 ± 16 years), SAPS II (51 ± 19), percentage of surgical admissions (40.0 %) and proportion of diabetic patients (20.3 %). A total of 431 (32.3 %) patients in the TGC group and 447 (34.1 %) in the CGC group had died by day 90 (odds ratio for death in the TGC 0.92; 95 % confidence interval 0.78–1.78; p = 0.32). Severe hypoglycemia (<2.2 mmol/L) occurred in 174 of 1,317 patients (13.2 %) in the TGC group and 79 of 1,284 patients (6.2 %) in the CGC group (p < 0.001).
Tight computerized glucose control with the CDSS did not significantly change 90-day mortality and was associated with more frequent severe hypoglycemia episodes in comparison with conventional glucose control.
KeywordsCritical care Glucose control Computerized decision-support systems ICU Mortality Randomized controlled trials
The CGAO–REA study was supported, in part, by the Société Francaise d’Anesthésie et de Réanimation (SFAR) and Baxter Healthcare Corporation. The study sponsor was Centre Hospitalier de Chartres, France. Dr. Kalfon is honored to have received the “Grand prix pour la Recherche 2008” from the Société Francaise d’Anesthésie et de Réanimation (SFAR) supporting the CGAO–REA study. We gratefully thank all members of the nursing staff of each participating ICU for their strong involvement and motivation in the study. We gratefully thank Amélie Le Gouge, and Mathieu Lemaire (INSERM Centre d’investigation clinique 202, Centre Hospitalier Universitaire de Tours), for participating in the statistical analysis; Gaëtan Roudillon and Gilles Rafalli (LK2, Saint-Avertin, France) for their major and invaluable role during the deployment of the software CGAO in 34 centers and for participating under the supervision of the lead investigator in training of clinical staffs and providing technical and educational support; Bérangère Bonnel, Cécile Jourdain, Dr Caroline Touboul, Patrick Piesvaux, Sylvie Aprelon, Emilie Breton, Isabelle Tessier and Leslie Leshayes (Hôpital Louis Pasteur, Centre Hospitalier de Chartres, Chartres) for their invaluable help in collecting data; Dr David Baker, DM, FRCA, (Department of Anesthesiology and Critical Care, Hôpital Necker-Enfants Malades, Paris) for reviewing the manuscript. Dr. Kalfon, and Mr. Giraudeau had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs. Kalfon, Ichai, Riou and Mr. Giraudeau participated in the study concept and design. Drs. Kalfon, Ichai, Brechot, Cinotti, Dequin, Riu-Poulenc, Montravers, Annane and Dupont participated in the acquisition of data. Drs. Kalfon, Riou, Ichai, Chastre (see ESM), Dequin, Montravers, Annane, Dupont, Mr. Giraudeau, Mr. Guerrini and Mr. Sorine participated in the analysis and interpretation of data. Drs. Kalfon, Ichai, Riou, Chastre (see ESM) and Mr. Giraudeau participated in the drafting of the manuscript and the critical revision of the manuscript for important intellectual content. Mr. Giraudeau performed the statistical analysis. Dr. Kalfon obtained funding. Drs. Kalfon, Ichai, Dequin, Montravers, Annane, Dupont, Riou, Mr. Giraudeau, Mr. Guerrini, and Mr. Sorine participated in the administrative, technical, or material support. The study supervision was performed by Dr. Kalfon.
Conflicts of interest
Dr. Kalfon is a board member of LK2 (Saint-Avertin, France) and has shares in LK2. On behalf of all remaining authors, the corresponding author states that the remaining authors have no conflict of interest.
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