Hydrocortisone therapy for patients with septic shock

Charles L Sprung, Djillali Annane, Didier Keh, Rui Moreno, Mervyn Singer, Klaus Freivogel, Yoram G Weiss, Julie Benbenishty, Armin Kalenka, Helmuth Forst, Pierre-Francois Laterre, Konrad Reinhart, Brian Cuthbertson, Didier Payen, Josef Briegel, CORTICUS Study Group

Research output: Contribution to journalArticle

1416 Citations (Scopus)

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.)
Original languageEnglish
Pages (from-to)111-124
Number of pages14
JournalThe New England Journal of Medicine
Volume358
Issue number2
DOIs
Publication statusPublished - 10 Jan 2008

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Septic Shock
Hydrocortisone
Adrenocorticotropic Hormone
Placebos
Shock
Therapeutics
Superinfection
Survival
Resuscitation
Sepsis

Keywords

  • Adrenal Glands
  • Adrenocorticotropic Hormone
  • Adult
  • Aged
  • Anesthetics, Intravenous
  • Anti-Inflammatory Agents
  • Double-Blind Method
  • Drug Therapy, Combination
  • Etomidate
  • Female
  • Hormones
  • Humans
  • Hydrocortisone
  • Injections, Intravenous
  • Kaplan-Meiers Estimate
  • Male
  • Middle Aged
  • Shock, Septic
  • Treatment Failure
  • Anti-inflammatory Agents

Cite this

Sprung, C. L., Annane, D., Keh, D., Moreno, R., Singer, M., Freivogel, K., ... CORTICUS Study Group (2008). Hydrocortisone therapy for patients with septic shock. The New England Journal of Medicine, 358(2), 111-124. https://doi.org/10.1056/NEJMoa071366

Hydrocortisone therapy for patients with septic shock. / Sprung, Charles L; Annane, Djillali; Keh, Didier; Moreno, Rui; Singer, Mervyn; Freivogel, Klaus; Weiss, Yoram G; Benbenishty, Julie; Kalenka, Armin; Forst, Helmuth; Laterre, Pierre-Francois; Reinhart, Konrad; Cuthbertson, Brian; Payen, Didier; Briegel, Josef; CORTICUS Study Group.

In: The New England Journal of Medicine, Vol. 358, No. 2, 10.01.2008, p. 111-124.

Research output: Contribution to journalArticle

Sprung, CL, Annane, D, Keh, D, Moreno, R, Singer, M, Freivogel, K, Weiss, YG, Benbenishty, J, Kalenka, A, Forst, H, Laterre, P-F, Reinhart, K, Cuthbertson, B, Payen, D, Briegel, J & CORTICUS Study Group 2008, 'Hydrocortisone therapy for patients with septic shock', The New England Journal of Medicine, vol. 358, no. 2, pp. 111-124. https://doi.org/10.1056/NEJMoa071366
Sprung CL, Annane D, Keh D, Moreno R, Singer M, Freivogel K et al. Hydrocortisone therapy for patients with septic shock. The New England Journal of Medicine. 2008 Jan 10;358(2):111-124. https://doi.org/10.1056/NEJMoa071366
Sprung, Charles L ; Annane, Djillali ; Keh, Didier ; Moreno, Rui ; Singer, Mervyn ; Freivogel, Klaus ; Weiss, Yoram G ; Benbenishty, Julie ; Kalenka, Armin ; Forst, Helmuth ; Laterre, Pierre-Francois ; Reinhart, Konrad ; Cuthbertson, Brian ; Payen, Didier ; Briegel, Josef ; CORTICUS Study Group. / Hydrocortisone therapy for patients with septic shock. In: The New England Journal of Medicine. 2008 ; Vol. 358, No. 2. pp. 111-124.
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T1 - Hydrocortisone therapy for patients with septic shock

AU - Sprung, Charles L

AU - Annane, Djillali

AU - Keh, Didier

AU - Moreno, Rui

AU - Singer, Mervyn

AU - Freivogel, Klaus

AU - Weiss, Yoram G

AU - Benbenishty, Julie

AU - Kalenka, Armin

AU - Forst, Helmuth

AU - Laterre, Pierre-Francois

AU - Reinhart, Konrad

AU - Cuthbertson, Brian

AU - Payen, Didier

AU - Briegel, Josef

AU - CORTICUS Study Group

N1 - 2008 Massachusetts Medical Society

PY - 2008/1/10

Y1 - 2008/1/10

N2 - 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.)

AB - 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.)

KW - Adrenal Glands

KW - Adrenocorticotropic Hormone

KW - Adult

KW - Aged

KW - Anesthetics, Intravenous

KW - Anti-Inflammatory Agents

KW - Double-Blind Method

KW - Drug Therapy, Combination

KW - Etomidate

KW - Female

KW - Hormones

KW - Humans

KW - Hydrocortisone

KW - Injections, Intravenous

KW - Kaplan-Meiers Estimate

KW - Male

KW - Middle Aged

KW - Shock, Septic

KW - Treatment Failure

KW - Anti-inflammatory Agents

U2 - 10.1056/NEJMoa071366

DO - 10.1056/NEJMoa071366

M3 - Article

VL - 358

SP - 111

EP - 124

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

SN - 0028-4793

IS - 2

ER -