title: Hydrocortisone therapy for patients with multiple trauma: the randomized controlled HYPOLYTE study.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00563303.
authors.affiliation: Department of Anesthesiology and Intensive Care Medicine, University of Nantes, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Roquilly
authors.forename: Pierre Joachim
authors.initials: PJ
authors.lastname: Mahe
authors.forename: Philippe
authors.initials: P
authors.lastname: Seguin
authors.forename: Christophe
authors.initials: C
authors.lastname: Guitton
authors.forename: Hervé
authors.initials: H
authors.lastname: Floch
authors.forename: Anne Charlotte
authors.initials: AC
authors.lastname: Tellier
authors.forename: Laurent
authors.initials: L
authors.lastname: Merson
authors.forename: Benoît
authors.initials: B
authors.lastname: Renard
authors.forename: Yannick
authors.initials: Y
authors.lastname: Malledant
authors.forename: Laurent
authors.initials: L
authors.lastname: Flet
authors.forename: Véronique
authors.initials: V
authors.lastname: Sebille
authors.forename: Christelle
authors.initials: C
authors.lastname: Volteau
authors.forename: Damien
authors.initials: D
authors.lastname: Masson
authors.forename: Jean Michel
authors.initials: JM
authors.lastname: Nguyen
authors.forename: Corinne
authors.initials: C
authors.lastname: Lejus
authors.forename: Karim
authors.initials: K
authors.lastname: Asehnoune
mesh_terms: D000293:Adolescent; D000309:Adrenal Insufficiency / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D003428:Cross Infection / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D007362:Intensive Care Units; D007442:Intubation, Intratracheal; D008297:Male; D008875:Middle Aged; D009104:Multiple Trauma / Q000150:complications*; D011014:Pneumonia / Q000209:etiology / Q000517:prevention & control*; D012121:Respiration, Artificial; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D006854:Hydrocortisone