dc.creator | Whitlock R.P., Devereaux P.J., Teoh K.H., Lamy A., Vincent J., Pogue J., Paparella D., Sessler D.I., Karthikeyan G., Villar J.C., Zuo Y., Avezum Á., Quantz M., Tagarakis G.I., Shah P.J., Abbasi S.H., Zheng H., Pettit S., Chrolavicius S., Yusuf S., SIRS Investigators | en |
dc.date.accessioned | 2023-01-31T11:37:26Z | |
dc.date.available | 2023-01-31T11:37:26Z | |
dc.date.issued | 2015 | |
dc.identifier | 10.1016/S0140-6736(15)00273-1 | |
dc.identifier.issn | 01406736 | |
dc.identifier.uri | http://hdl.handle.net/11615/80797 | |
dc.description.abstract | Background Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. 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 Methylprednisolone did not have a significant effect on mortality or major morbidity after cardiac surgery with cardiopulmonary bypass. The SIRS trial does not support the routine use of methylprednisolone for patients undergoing cardiopulmonary bypass. Funding Canadian Institutes of Health Research. © 2015 Elsevier Ltd. | en |
dc.language.iso | en | en |
dc.source | The Lancet | en |
dc.source.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84943387787&doi=10.1016%2fS0140-6736%2815%2900273-1&partnerID=40&md5=2b63faf0ba3a6675af37bc8097ef3d3a | |
dc.subject | glucose | en |
dc.subject | insulin | en |
dc.subject | methylprednisolone | en |
dc.subject | antiinflammatory agent | en |
dc.subject | methylprednisolone | en |
dc.subject | aged | en |
dc.subject | anesthesia induction | en |
dc.subject | Article | en |
dc.subject | atrial fibrillation | en |
dc.subject | bacterial infection | en |
dc.subject | cardiac patient | en |
dc.subject | cardiopulmonary bypass | en |
dc.subject | cardiovascular mortality | en |
dc.subject | caregiver | en |
dc.subject | cerebrovascular accident | en |
dc.subject | chest tube | en |
dc.subject | controlled study | en |
dc.subject | coronary artery bypass surgery | en |
dc.subject | delirium | en |
dc.subject | double blind procedure | en |
dc.subject | female | en |
dc.subject | follow up | en |
dc.subject | glucose blood level | en |
dc.subject | heart muscle injury | en |
dc.subject | human | en |
dc.subject | intensive care unit | en |
dc.subject | kidney failure | en |
dc.subject | major clinical study | en |
dc.subject | male | en |
dc.subject | medical history | en |
dc.subject | multicenter study | en |
dc.subject | mycosis | en |
dc.subject | parallel design | en |
dc.subject | patient safety | en |
dc.subject | postoperative period | en |
dc.subject | priority journal | en |
dc.subject | Q wave | en |
dc.subject | randomized controlled trial | en |
dc.subject | respiratory failure | en |
dc.subject | steroid therapy | en |
dc.subject | surgical infection | en |
dc.subject | very elderly | en |
dc.subject | adverse effects | en |
dc.subject | cardiopulmonary bypass | en |
dc.subject | clinical trial | en |
dc.subject | middle aged | en |
dc.subject | mortality | en |
dc.subject | procedures | en |
dc.subject | systemic inflammatory response syndrome | en |
dc.subject | Aged | en |
dc.subject | Aged, 80 and over | en |
dc.subject | Anti-Inflammatory Agents | en |
dc.subject | Cardiopulmonary Bypass | en |
dc.subject | Double-Blind Method | en |
dc.subject | Female | en |
dc.subject | Humans | en |
dc.subject | Male | en |
dc.subject | Methylprednisolone | en |
dc.subject | Middle Aged | en |
dc.subject | Systemic Inflammatory Response Syndrome | en |
dc.subject | Lancet Publishing Group | en |
dc.title | Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): A randomised, double-blind, placebo-controlled trial | en |
dc.type | journalArticle | en |