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Title: Adjunctive Glucocorticoid Therapy in Patients with Septic Shock
Austin Authors: Venkatesh, Balasubramanian;Finfer, Simon;Cohen, Jeremy;Rajbhandari, Dorrilyn;Arabi, Yaseen;Bellomo, Rinaldo ;Billot, Laurent;Correa, Maryam;Glass, Parisa;Harward, Meg;Joyce, Christopher;Li, Qiang;McArthur, Colin;Perner, Anders;Rhodes, Andrew;Thompson, Kelly;Webb, Steve;Myburgh, John
Affiliation: From the George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
St. George Clinical School, St. George Hospital, Sydney, New South Wales, Australia
Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia
Royal North Shore Hospital, Sydney, New South Wales, Australia
Princess Alexandra Hospital, Brisbane, Queensland, Australia
Royal Brisbane and Women's HospitalBrisbane, Queensland, Australia
Wesley Hospital, Brisbane, Queensland, Australia
Austin Health, Heidelberg, Victoria, Australia
School of Medicine, University of Melbourne, Melbourne, Victoria, Australia
Australian and New Zealand Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia, Australia
King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia
Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand
Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
St. George's University Hospitals NHS Foundation Trust, St. George's University of London, London, UK
Issue Date: 19-Jan-2018 2018
Publication information: The New England Journal of Medicine 2018; 378(9): 797-808
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. (Funded by the National Health and Medical Research Council of Australia and others; ADRENAL number, NCT01448109 .).
DOI: 10.1056/NEJMoa1705835
ORCID: 0000-0002-4975-9793
Journal: The New England Journal of Medicine
PubMed URL: 29347874
PubMed URL:
Type: Journal Article
Appears in Collections:Journal articles

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