PMID- 21427372
OWN - NLM
STAT- MEDLINE
DCOM- 20110324
LR  - 20161017
IS  - 1538-3598 (Electronic)
IS  - 0098-7484 (Linking)
VI  - 305
IP  - 12
DP  - 2011 Mar 23
TI  - Hydrocortisone therapy for patients with multiple trauma: the randomized 
      controlled HYPOLYTE study.
PG  - 1201-9
LID - 10.1001/jama.2011.360 [doi]
AB  - 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.
FAU - Roquilly, Antoine
AU  - Roquilly A
AD  - Department of Anesthesiology and Intensive Care Medicine, University of Nantes, 
      France.
FAU - Mahe, Pierre Joachim
AU  - Mahe PJ
FAU - Seguin, Philippe
AU  - Seguin P
FAU - Guitton, Christophe
AU  - Guitton C
FAU - Floch, Herve
AU  - Floch H
FAU - Tellier, Anne Charlotte
AU  - Tellier AC
FAU - Merson, Laurent
AU  - Merson L
FAU - Renard, Benoit
AU  - Renard B
FAU - Malledant, Yannick
AU  - Malledant Y
FAU - Flet, Laurent
AU  - Flet L
FAU - Sebille, Veronique
AU  - Sebille V
FAU - Volteau, Christelle
AU  - Volteau C
FAU - Masson, Damien
AU  - Masson D
FAU - Nguyen, Jean Michel
AU  - Nguyen JM
FAU - Lejus, Corinne
AU  - Lejus C
FAU - Asehnoune, Karim
AU  - Asehnoune K
LA  - eng
SI  - ClinicalTrials.gov/NCT00563303
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
RN  - 0 (Anti-Inflammatory Agents)
RN  - WI4X0X7BPJ (Hydrocortisone)
SB  - IM
CIN - JAMA. 2011 Mar 23;305(12):1242-3. PMID: 21427379
CIN - JAMA. 2011 Jul 6;306(1):40-1; author reply 42. PMID: 21730236
CIN - JAMA. 2011 Jul 6;306(1):41; author reply 42. PMID: 21730237
CIN - JAMA. 2011 Jul 6;306(1):41; author reply 42. PMID: 21730238
CIN - Crit Care. 2012;16(1):301. PMID: 22264304
MH  - Adolescent
MH  - Adrenal Insufficiency/diagnosis/drug therapy/etiology
MH  - Adult
MH  - Anti-Inflammatory Agents/*therapeutic use
MH  - Cross Infection/etiology/*prevention & control
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hydrocortisone/*therapeutic use
MH  - Infusions, Intravenous
MH  - Intensive Care Units
MH  - Intubation, Intratracheal
MH  - Male
MH  - Middle Aged
MH  - Multiple Trauma/*complications
MH  - Pneumonia/etiology/*prevention & control
MH  - Respiration, Artificial
MH  - Young Adult
EDAT- 2011/03/24 06:00
MHDA- 2011/03/25 06:00
CRDT- 2011/03/24 06:00
PHST- 2011/03/24 06:00 [entrez]
PHST- 2011/03/24 06:00 [pubmed]
PHST- 2011/03/25 06:00 [medline]
AID - 305/12/1201 [pii]
AID - 10.1001/jama.2011.360 [doi]
PST - ppublish
SO  - JAMA. 2011 Mar 23;305(12):1201-9. doi: 10.1001/jama.2011.360.