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https://hdl.handle.net/2440/135382
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Type: | Journal article |
Title: | Adjunctive glucocorticoid therapy in patients with septic shock |
Author: | Venkatesh, B. Finfer, S. Cohen, J. Rajbhandari, D. Arabi, Y. Bellomo, R. Billot, L. Correa, M. Glass, P. Harward, M. Joyce, C. Li, Q. McArthur, C. Perner, A. Rhodes, A. Thompson, K. Webb, S. Myburgh, J. |
Citation: | New England Journal of Medicine, 2018; 378(9):797-808 |
Publisher: | Massachusetts Medical Society |
Issue Date: | 2018 |
ISSN: | 0028-4793 1533-4406 |
Statement of Responsibility: | B. Venkatesh, S. Finfer, J. Cohen, D. Rajbhandari, Y. Arabi, R. Bellomo, L. Billot, M. Correa, P. Glass, M. Harward, C. Joyce, Q. Li, C. McArthur, A. Perner, A. Rhodes, K. Thompson, S. Webb, and J. Myburgh, for the ADRENAL Trial Investigators and the Australian, New Zealand Intensive Care Society Clinical Trials Group |
Abstract: | BACKGROUND Whether hydrocortisone reduces mortality among patients with septic shock is unclear. METHODS We randomly assigned patients with septic shock who were undergoing mechanical ventilation to receive hydrocortisone (at a dose of 200 mg per day) or placebo for 7 days or until death or discharge from the intensive care unit (ICU), whichever came first. The primary outcome was death from any cause at 90 days. RESULTS From March 2013 through April 2017, a total of 3800 patients underwent randomization. Status with respect to the primary outcome was ascertained in 3658 patients (1832 of whom had been assigned to the hydrocortisone group and 1826 to the placebo group). At 90 days, 511 patients (27.9%) in the hydrocortisone group and 526 (28.8%) in the placebo group had died (odds ratio, 0.95; 95% confidence interval [CI], 0.82 to 1.10; P = 0.50). The effect of the trial regimen was similar in six prespecified subgroups. Patients who had been assigned to receive hydrocortisone had faster resolution of shock than those assigned to the placebo group (median duration, 3 days [interquartile range, 2 to 5] vs. 4 days [interquartile range, 2 to 9]; hazard ratio, 1.32; 95% CI, 1.23 to 1.41; P<0.001). Patients in the hydrocortisone group had a shorter duration of the initial episode of mechanical ventilation than those in the placebo group (median, 6 days [interquartile range, 3 to 18] vs. 7 days [interquartile range, 3 to 24]; hazard ratio, 1.13; 95% CI, 1.05 to 1.22; P<0.001), but taking into account episodes of recurrence of ventilation, there were no significant differences in the number of days alive and free from mechanical ventilation. Fewer patients in the hydrocortisone group than in the placebo group received a blood transfusion (37.0% vs. 41.7%; odds ratio, 0.82; 95% CI, 0.72 to 0.94; P = 0.004). There were no significant between-group differences with respect to mortality at 28 days, the rate of recurrence of shock, the number of days alive and out of the ICU, the number of days alive and out of the hospital, the recurrence of mechanical ventilation, the rate of renal-replacement therapy, and the incidence of new-onset bacteremia or fungemia. CONCLUSIONS Among patients with septic shock undergoing mechanical ventilation, a continuous infusion of hydrocortisone did not result in lower 90-day mortality than placebo. |
Keywords: | ADRENAL Trial Investigators and the Australian–New Zealand Intensive Care Society Clinical Trials Group Humans Bacteremia Fungemia Shock, Septic Recurrence Hydrocortisone Anti-Inflammatory Agents Treatment Outcome Chemotherapy, Adjuvant Respiration, Artificial Renal Replacement Therapy Infusions, Intravenous APACHE Survival Rate Double-Blind Method Aged Middle Aged Female Male |
Rights: | Copyright © 2018 Massachusetts Medical Society. All rights reserved. |
DOI: | 10.1056/NEJMoa1705835 |
Grant ID: | http://purl.org/au-research/grants/nhmrc/1004108 http://purl.org/au-research/grants/nhmrc/1124926 |
Published version: | http://dx.doi.org/10.1056/nejmoa1705835 |
Appears in Collections: | Medicine publications |
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