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Research

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SIRS

Official Title

Steroids In caRdiac Surgery Trial (SIRS Trial). A Phase 3 Study of Perioperative Steroid’s Effects on Death or MI in Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass

Status

Ongoing

Overview

Multicentre, international, randomized, controlled, double-blind placebo-controlled trial of high-risk adult patients undergoing cardiopulmonary bypass. Patients will be randomly allocated to receive 500 mg of methylprednisolone divided into two intravenous doses of 250 mg each, one during anesthetic induction and the other on CPB initiation, or matching placebo.

Study Design

Randomized, double-blind, treatment, placebo control, parallel group design, safety/efficacy.

Primary Endpoint

Adjudicated. 1) Total mortality within 30 days post-surgery and 2) Composite of total mortality, MI, stroke, renal failure, or respiratory failure within 30 days post-surgery

Number of Patients

7507

Number of Sites

80

Number of Countries

18

Study Period

2007–2014

Principal Investigator

Richard Whitlock

Program Manager

Susan Chrolavicius, Shirley Pettit

Research Coordinator

Jessica Vincent

Collaborators

CIHR

Key Publications

  • Whitlock R, Teoh K, Vincent J, Devereaux PJ, Lamy A, Paparella D, Zuo Y, Sessler DI, Shah P, Villar JC, Karthikeyan G, Urrutia G, Alvezum A, Zhang X, Abbasi SH, Zheng H, Quantz M, Yared JP, Yu H, Noiseux N, and S Yusuf. Rationale and design of the Steroids in Cardiac Surgery trial. American Heart Journal, 2014; 167:660-5.
  • Garg AX, Vincent J, Cuerden M, Parikh C, Devereaux PJ, Teoh K, Yusuf S, Hildebrand A, Lamy A, Zuo Y, Sessler DI, Shah P, Abbasi SH, Quantz M, Yared JP, Noiseux N, Tagarakis G, Rochon A, Pogue J, Walsh M, Chan MT, Lamontagne F, Salehiomran A, Whitlock R; SIRS Investigators. Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial. BMJ Open. 2014 Mar 5;4(3):e004842. doi: 10.1136/bmjopen-2014-004842.