1. Hydrocortisone therapy for patients with multiple trauma: the randomized controlled HYPOLYTE study
- Author
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Laurent Merson, Laurent Flet, Antoine Roquilly, Philippe Seguin, Benoit Renard, Jean Michel Nguyen, Hervé Floch, Pierre Joachim Mahe, Karim Asehnoune, Damien Masson, Christelle Volteau, Christophe Guitton, Anne Charlotte Tellier, Corinne Lejus, Yannick Mallédant, Véronique Sébille, Service d'anesthésie réanimation chirurgicale [Rennes], Hôpital Pontchaillou-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Foie, métabolismes et cancer, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Service de Réanimation Médicale, Hôtel-Dieu-Centre hospitalier universitaire de Nantes (CHU Nantes), Biostatistique, Recherche Clinique et Mesures Subjectives en Santé, Université de Nantes (UN), Service d'anesthésie et réanimation chirurgicale [Nantes], Université de Rennes (UR)-Hôpital Pontchaillou, and Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )
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medicine.medical_specialty ,MESH: Pneumonia ,medicine.drug_class ,Context (language use) ,Placebo ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Intensive care ,medicine ,MESH: Double-Blind Method ,030212 general & internal medicine ,MESH: Respiration, Artificial ,MESH: Infusions, Intravenous ,Hydrocortisone ,MESH: Adolescent ,MESH: Middle Aged ,MESH: Humans ,MESH: Intubation, Intratracheal ,business.industry ,MESH: Multiple Trauma ,MESH: Cross Infection ,030208 emergency & critical care medicine ,MESH: Adult ,[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,General Medicine ,medicine.disease ,Intensive care unit ,MESH: Male ,MESH: Hydrocortisone ,3. Good health ,Surgery ,MESH: Young Adult ,Anesthesia ,MESH: Adrenal Insufficiency ,MESH: Anti-Inflammatory Agents ,Corticosteroid ,MESH: Intensive Care Units ,business ,Hyponatremia ,MESH: Female ,medicine.drug - Abstract
International audience; CONTEXT: The role of stress-dose hydrocortisone in the management of trauma patients is currently unknown. OBJECTIVE: To test the efficacy of hydrocortisone therapy in trauma patients. DESIGN, SETTING, AND PATIENTS: Multicenter, randomized, double-blind, placebo-controlled HYPOLYTE (Hydrocortisone Polytraumatise) study. From November 2006 to August 2009, 150 patients with severe trauma were included in 7 intensive care units in France. INTERVENTION: Patients were randomly assigned to a continuous intravenous infusion of either hydrocortisone (200 mg/d for 5 days, followed by 100 mg on day 6 and 50 mg on day 7) or placebo. The treatment was stopped if patients had an appropriate adrenal response. MAIN OUTCOME MEASURE: Hospital-acquired pneumonia within 28 days. Secondary outcomes included the duration of mechanical ventilation, hyponatremia, and death. RESULTS: One patient withdrew consent. An intention-to-treat (ITT) analysis included the 149 patients, a modified ITT analysis included 113 patients with corticosteroid insufficiency. In the ITT analysis, 26 of 73 patients (35.6%) treated with hydrocortisone and 39 of 76 patients (51.3%) receiving placebo developed hospital-acquired pneumonia by day 28 (hazard ratio [HR], 0.51; 95% confidence interval [CI], 0.30-0.83; P = .007). In the modified ITT analysis, 20 of 56 patients (35.7%) in the hydrocortisone group and 31 of 57 patients (54.4%) in the placebo group developed hospital-acquired pneumonia by day 28 (HR, 0.47; 95% CI, 0.25-0.86; P = .01). Mechanical ventilation-free days increased with hydrocortisone by 4 days (95% CI, 2-7; P = .001) in the ITT analysis and 6 days (95% CI, 2-11; P < .001) in the modified ITT analysis. Hyponatremia was observed in 7 of 76 (9.2%) in the placebo group vs none in the hydrocortisone group (absolute difference, -9%; 95% CI, -16% to -3%; P = .01). Four of 76 patients (5.3%) in the placebo group and 6 of 73 (8.2%) in the hydrocortisone group died (absolute difference, 3%; 95% CI, -5% to 11%; P = .44). CONCLUSION: In intubated trauma patients, the use of an intravenous stress-dose of hydrocortisone, compared with placebo, resulted in a decreased risk of hospital-acquired pneumonia. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00563303.
- Published
- 2011
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