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2. Tight Computerized versus Conventional Glucose Control in the ICU. A Randomized Controlled Study

Author

Raphaël Cinotti, Djilalli Annane, Nicolas Bréchot, Pierre-François Dequin, Pierre Kalfon, Bruno Giraudeau, Béatrice Riu-Poulenc, Michel Sorine, Alexandre Guerrini, C. Ichai, Hervé Dupont, Bruno Riou, Philippe Montravers, Service de Réanimation polyvalente [Chartres], Hôpital Louis Pasteur [Chartres], Génétique, pharmacologie et physiopathologie des maladies cardiovasculaires [Paris], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC), Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Réanimation médico-chirurgicale [Nice], Hôpital Saint-Roch [Nice], LK2, Service de Pneumologie – Réanimation Médicale [CHU Pitié-Salpêtrière], Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], CHU Pontchaillou [Rennes], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Service de Réanimation polyvalente [Toulouse], CHU Toulouse [Toulouse], Service d'anesthésie - réanimation chirurgicale [CHU Bichat], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Service de physiologie et d'explorations fonctionnelles [CHU Raymond-Poincaré], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Raymond Poincaré [AP-HP], CHU Amiens-Picardie, SIgnals and SYstems in PHysiology & Engineering (SISYPHE), Inria Paris-Rocquencourt, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), Université Pierre et Marie Curie - Paris 6 - UFR de Médecine Pierre et Marie Curie (UPMC), Université Pierre et Marie Curie - Paris 6 (UPMC), Génétique, pharmacologie et physiopathologie des maladies cardiovasculaires [CHU Pitié-Salpétriêre], Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Réanimation polyvalente [CHU Toulouse], Pôle Anesthésie Réanimation [CHU de Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle IUCT [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre d’Investigation Clinique [Tours] (CIC), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Service de cardiologie et maladies vasculaires, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Université Paris Diderot - Paris 7 (UPD7), Service de physiologie et d'explorations fonctionnelles, AP-HP Hôpital Raymond Poincaré [Garches]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier universitaire d'Amiens (CHU Amiens-Picardie), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université, Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)

Subjects
Blood Glucose, Male, medicine.medical_specialty, Randomization, Blinding, Critical Care and Intensive Care Medicine, law.invention, Randomized controlled trial, law, Internal medicine, Anesthesiology, [INFO.INFO-AU]Computer Science [cs]/Automatic Control Engineering, Glucose control, medicine, Humans, Hypoglycemic Agents, Insulin, Mortality, business.industry, Odds ratio, Middle Aged, Computerized decision-support systems, Intensive care unit, Confidence interval, 3. Good health, Surgery, Drug Therapy, Computer-Assisted, Intensive Care Units, Critical care, SAPS II, ICU, Randomized controlled trials, Female, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; Purpose: Both the blood glucose target range in critically ill adult patients and the optimal method to reach this target range remain a matter of debate. To test whether a Computer Decision Support System (CDSS) might improve the outcome of critically ill adult patients through facilitation of a tighter blood glucose control. Methods: We conducted a multicenter randomized trial in 34 French closed-format intensive care units in 19 university hospitals and 15 nonuniversity hospitals from October 2009 to June 2011. Adult patients who were expected to require treatment in the ICU at least 3 days were randomly assigned without blinding to undergo tight computerized glucose control with CDSS or conventional glucose control, with the respective blood glucose targets of 80 to 110 and < 180 mg per deciliter. The primary outcome was all-cause death within 90 days after ICU admission. Results: Of the 2,684 patients who underwent randomization, 1,351 were assigned to tight computerized glucose control and 1,333 to conventional glucose control. Data with regard to the primary outcome were available for 1,335 and 1,311 patients, respectively. A total of 431 (32.3%) patients in the tight computerized glucose control group and 447 (34.1%) in the conventional glucose control group died at day 90 (odds ratio for death in the tight computerized glucose control, 0.92; 95% CI, 0.78-1.78; p = 0.32). Severe hypoglycemia (< 40 mg/dL) was reported in 174 of 1,317 patients (13.2%) in the tight computerized glucose control group and 79 of 1,284 patients (6.2%) in the conventional glucose control group (p < 0.001). Conclusions: In critically ill patients, tight computerized glucose control with CDSS did not significantly change 90-day mortality and is associated with more frequent severe hypoglycemia in comparison with conventional glucose control performed without CDSS.

Published
2014
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3. Tight computerized versus conventional glucose control in the ICU: a randomized controlled trial.

Author

Kalfon P, Giraudeau B, Ichai C, Guerrini A, Brechot N, Cinotti R, Dequin PF, Riu-Poulenc B, Montravers P, Annane D, Dupont H, Sorine M, and Riou B

Subjects
Female, Humans, Intensive Care Units, Male, Middle Aged, Blood Glucose analysis, Critical Care methods, Drug Therapy, Computer-Assisted, Hypoglycemic Agents therapeutic use, Insulin therapeutic use
Abstract

Purpose: 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., Methods: 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., Results: 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)., Conclusions: 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.

Published
2014
Full Text
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