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Caring for the Critically Ill Patient
March 23 2011

Hydrocortisone Therapy for Patients With Multiple Trauma: The Randomized Controlled HYPOLYTE Study

Author Affiliations

Author Affiliations: Departments of Anesthesiology and Intensive Care Medicine (Drs Roquilly, Mahe, Lejus, and Asehnoune), Medical Intensive Care (Dr Guitton), Pharmacy (Dr Flet), Biostatistics and Biometry (Dr Sebille and Ms Volteau), Biology (Dr Masson), and Epidemiology and Biostatistics (Dr Nguyen), University Hospital of Nantes, and University of Pharmacy (Dr Sebille), University of Nantes; Department of Anesthesiology and Intensive Care Medicine, University Hospital of Rennes, University of Rennes (Drs Seguin and Malledant); Department of Anesthesiology and Intensive Care Medicine, University Hospital of Brest, University of Brest (Dr Floch); Department of Anesthesiology and Intensive Care Medicine, University Hospital of Tours, University of Tours (Dr Tellier); Department of Anesthesiology and Intensive Care Medicine, University Hospital of Bordeaux, University of Bordeaux (Dr Merson); and Department of Critical Care, General Hospital of La Roche Sur Yon, La Roche Sur Yon, and Department of Internal Medicine, Les Sables d’Olonne, Les Sables d’Olonne (Dr Renard), France.

JAMA. 2011;305(12):1201-1209. doi:10.1001/jama.2011.360

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