Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial.
Abstract | BACKGROUND: METHODS: The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388. FINDINGS: Patients were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone, compared with placebo, did not reduce the risk of death at 30 days (154 [4%] vs 177 [5%] patients; relative risk [RR] 0·87, 95% CI 0·70-1·07, p=0·19) or the risk of death or major morbidity (909 [24%] vs 885 [24%]; RR 1·03, 95% CI 0·95-1·11, p=0·52). The most common safety outcomes in the methylprednisolone and placebo group were infection (465 [12%] vs 493 [13%]), surgical site infection (151 [4%] vs 151 [4%]), and delirium (295 [8%] vs 289 [8%]). INTERPRETATION: FUNDING: Canadian Institutes of Health Research.
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Authors | Richard P Whitlock, P J Devereaux, Kevin H Teoh, Andre Lamy, Jessica Vincent, Janice Pogue, Domenico Paparella, Daniel I Sessler, Ganesan Karthikeyan, Juan Carlos Villar, Yunxia Zuo, Álvaro Avezum, Mackenzie Quantz, Georgios I Tagarakis, Pallav J Shah, Seyed Hesameddin Abbasi, Hong Zheng, Shirley Pettit, Susan Chrolavicius, Salim Yusuf, SIRS Investigators |
Journal | Lancet (London, England)
(Lancet)
Vol. 386
Issue 10000
Pg. 1243-1253
(Sep 26 2015)
ISSN: 1474-547X [Electronic] England |
PMID | 26460660
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 Elsevier Ltd. All rights reserved. |
Chemical References |
- Anti-Inflammatory Agents
- Methylprednisolone
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Topics |
- Aged
- Aged, 80 and over
- Anti-Inflammatory Agents
(therapeutic use)
- Cardiopulmonary Bypass
(adverse effects, methods, mortality)
- Double-Blind Method
- Female
- Humans
- Male
- Methylprednisolone
(therapeutic use)
- Middle Aged
- Systemic Inflammatory Response Syndrome
(etiology, prevention & control)
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