title: Hydrocortisone therapy for patients with septic shock.
abstract: BACKGROUND
  Hydrocortisone is widely used in patients with septic shock even though a survival benefit has been reported only in patients who remained hypotensive after fluid and vasopressor resuscitation and whose plasma cortisol levels did not rise appropriately after the administration of corticotropin.
  
  
  METHODS
  In this multicenter, randomized, double-blind, placebo-controlled trial, we assigned 251 patients to receive 50 mg of intravenous hydrocortisone and 248 patients to receive placebo every 6 hours for 5 days; the dose was then tapered during a 6-day period. At 28 days, the primary outcome was death among patients who did not have a response to a corticotropin test.
  
  
  RESULTS
  Of the 499 patients in the study, 233 (46.7%) did not have a response to corticotropin (125 in the hydrocortisone group and 108 in the placebo group). At 28 days, there was no significant difference in mortality between patients in the two study groups who did not have a response to corticotropin (39.2% in the hydrocortisone group and 36.1% in the placebo group, P=0.69) or between those who had a response to corticotropin (28.8% in the hydrocortisone group and 28.7% in the placebo group, P=1.00). At 28 days, 86 of 251 patients in the hydrocortisone group (34.3%) and 78 of 248 patients in the placebo group (31.5%) had died (P=0.51). In the hydrocortisone group, shock was reversed more quickly than in the placebo group. However, there were more episodes of superinfection, including new sepsis and septic shock.
  
  
  CONCLUSIONS
  Hydrocortisone did not improve survival or reversal of shock in patients with septic shock, either overall or in patients who did not have a response to corticotropin, although hydrocortisone hastened reversal of shock in patients in whom shock was reversed. (ClinicalTrials.gov number, NCT00147004.)
authors.affiliation: Hadassah Hebrew University Medical Center, Jerusalem, Israel 91120. sprung@cc.huji.ac.il
authors.forename: Charles L
authors.initials: CL
authors.lastname: Sprung
authors.forename: Djillali
authors.initials: D
authors.lastname: Annane
authors.forename: Didier
authors.initials: D
authors.lastname: Keh
authors.forename: Rui
authors.initials: R
authors.lastname: Moreno
authors.forename: Mervyn
authors.initials: M
authors.lastname: Singer
authors.forename: Klaus
authors.initials: K
authors.lastname: Freivogel
authors.forename: Yoram G
authors.initials: YG
authors.lastname: Weiss
authors.forename: Julie
authors.initials: J
authors.lastname: Benbenishty
authors.forename: Armin
authors.initials: A
authors.lastname: Kalenka
authors.forename: Helmuth
authors.initials: H
authors.lastname: Forst
authors.forename: Pierre-Francois
authors.initials: PF
authors.lastname: Laterre
authors.forename: Konrad
authors.initials: K
authors.lastname: Reinhart
authors.forename: Brian H
authors.initials: BH
authors.lastname: Cuthbertson
authors.forename: Didier
authors.initials: D
authors.lastname: Payen
authors.forename: Josef
authors.initials: J
authors.lastname: Briegel
mesh_terms: D000311:Adrenal Glands / Q000187:drug effects / Q000378:metabolism; D000324:Adrenocorticotropic Hormone / Q000494:pharmacology; D000328:Adult; D000368:Aged; D018686:Anesthetics, Intravenous / Q000494:pharmacology; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005045:Etomidate / Q000494:pharmacology; D005260:Female; D006728:Hormones / Q000494:pharmacology; D006801:Humans; D006854:Hydrocortisone / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D007275:Injections, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012772:Shock, Septic / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality; D017211:Treatment Failure
chemical_list: D018686:Anesthetics, Intravenous; D000893:Anti-Inflammatory Agents; D006728:Hormones; D000324:Adrenocorticotropic Hormone; D006854:Hydrocortisone; D005045:Etomidate