Effect of Hydrocortisone on Development of Shock Among Patients With Severe Sepsis: The HYPRESS Randomized Clinical Trial.
Abstract | Importance: Objective: Design, Setting, and Participants: Double-blind, randomized clinical trial conducted from January 13, 2009, to August 27, 2013, with a follow-up of 180 days until February 23, 2014. The trial was performed in 34 intermediate or intensive care units of university and community hospitals in Germany, and it included 380 adult patients with severe sepsis who were not in septic shock. Interventions: Patients were randomly allocated 1:1 either to receive a continuous infusion of 200 mg of hydrocortisone for 5 days followed by dose tapering until day 11 (n = 190) or to receive placebo (n = 190). Main Outcomes and Measures: Results: The intention-to-treat population consisted of 353 patients (64.9% male; mean [SD] age, 65.0 [14.4] years). Septic shock occurred in 36 of 170 patients (21.2%) in the hydrocortisone group and 39 of 170 patients (22.9%) in the placebo group (difference, -1.8%; 95% CI, -10.7% to 7.2%; P = .70). No significant differences were observed between the hydrocortisone and placebo groups for time until septic shock; mortality in the intensive care unit or in the hospital; or mortality at 28 days (15 of 171 patients [8.8%] vs 14 of 170 patients [8.2%], respectively; difference, 0.5%; 95% CI, -5.6% to 6.7%; P = .86), 90 days (34 of 171 patients [19.9%] vs 28 of 168 patients [16.7%]; difference, 3.2%; 95% CI, -5.1% to 11.4%; P = .44), and 180 days (45 of 168 patients [26.8%] vs 37 of 167 patients [22.2%], respectively; difference, 4.6%; 95% CI, -4.6% to 13.7%; P = .32). In the hydrocortisone vs placebo groups, 21.5% vs 16.9% had secondary infections, 8.6% vs 8.5% had weaning failure, 30.7% vs 23.8% had muscle weakness, and 90.9% vs 81.5% had hyperglycemia. Conclusions and Relevance: Trial Registration: clinicaltrials.gov Identifier: NCT00670254.
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Authors | Didier Keh, Evelyn Trips, Gernot Marx, Stefan P Wirtz, Emad Abduljawwad, Sven Bercker, Holger Bogatsch, Josef Briegel, Christoph Engel, Herwig Gerlach, Anton Goldmann, Sven-Olaf Kuhn, Lars Hüter, Andreas Meier-Hellmann, Axel Nierhaus, Stefan Kluge, Josefa Lehmke, Markus Loeffler, Michael Oppert, Kerstin Resener, Dirk Schädler, Tobias Schuerholz, Philipp Simon, Norbert Weiler, Andreas Weyland, Konrad Reinhart, Frank M Brunkhorst, SepNet–Critical Care Trials Group |
Journal | JAMA
(JAMA)
Vol. 316
Issue 17
Pg. 1775-1785
(Nov 01 2016)
ISSN: 1538-3598 [Electronic] United States |
PMID | 27695824
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents
- Hydrocortisone
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Topics |
- Adult
- Aged
- Anti-Inflammatory Agents
(administration & dosage, adverse effects)
- Delirium
(diagnosis)
- Disease Progression
- Double-Blind Method
- Drug Administration Schedule
- Female
- Hospital Mortality
- Humans
- Hydrocortisone
(administration & dosage, adverse effects)
- Intensive Care Units
- Intention to Treat Analysis
(statistics & numerical data)
- Male
- Middle Aged
- Sepsis
(complications, mortality)
- Shock, Septic
(mortality, prevention & control)
- Time Factors
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