Rationale and design of the steroids in cardiac surgery trial.
BACKGROUND
Steroids may improve outcomes in high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CBP). There is a need\ for a large randomized controlled trial to clarify the effect of steroids in such patients.


METHODS
We plan to randomize 7,500 patients with elevated European System for Cardiac Operative Risk Evaluation who are undergoing cardiac surgery with the use of CBP to methylprednisolone or placebo. The first coprimary outcome is 30-day all-cause mortality, and the most second coprimary outcome is a composite of death, MI, stroke, renal failure, or respiratory failure within 30 days. Other outcomes include a composite of MI or mortality at 30 days, new onset atrial fibrillation, bleeding and transfusion requirements, length of intensive care unit stay and hospital stay, infection, stroke, wound complications, gastrointestinal complications, delirium, postoperative insulin use and peak blood glucose, and all-cause mortality at 6 months.


RESULTS
As of October 22, 2013, 7,034 patients have been recruited into SIRS in 82 centers from 18 countries. Patient's mean age is 67.3 years, and 60.4% are male. The average European System for Cardiac Operative Risk Evaluation is 7.0 with 22.1% having an isolated coronary artery bypass graft procedure, and 66.1% having a valve procedure.


CONCLUSIONS
SIRS will lead to a better understanding of the safety and efficacy of prophylactic steroids for cardiac surgery requiring CBP.
Population Health Research Institute, McMaster University/Hamilton Health Sciences, Hamilton, Canada. Electronic address: Richard.Whitlock@phri.ca.
Richard
R
Whitlock
Population Health Research Institute, McMaster University/Hamilton Health Sciences, Hamilton, Canada.
Kevin
K
Teoh
Population Health Research Institute, McMaster University/Hamilton Health Sciences, Hamilton, Canada.
Jessica
J
Vincent
Population Health Research Institute, McMaster University/Hamilton Health Sciences, Hamilton, Canada.
P J
PJ
Devereaux
Population Health Research Institute, McMaster University/Hamilton Health Sciences, Hamilton, Canada.
Andre
A
Lamy
University of Bari Aldo Moro, Bari, Italy.
Domenico
D
Paparella
West China Hospital, Sichuan University, Chengdu, China.
Yunxia
Y
Zuo
Department of Outcomes Research, Cleveland Clinic, Cleveland, OH.
Daniel I
DI
Sessler
Princess Alexandra Hospital, Woolloongabba, Australia.
Pallav
P
Shah
Fundación Cardio Infantil-Instituto de Cardiología, Bogotá, Colombia.
Juan-Carlos
JC
Villar
All India Institute of Medical Sciences, New Delhi, India.
Ganesan
G
Karthikeyan
Institut d'Investigació Biomèdica Sant Pau-CIBERESP, Barcelona, Spain.
Gerard
G
Urrútia
Divisão de Pesquisa, Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil.
Alvaro
A
Alvezum
Population Health Research Institute, McMaster University/Hamilton Health Sciences, Hamilton, Canada.
Xiaohe
X
Zhang
Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
Seyed Hesameddin
SH
Abbasi
First Teaching Hospital of Xinjiang Medical University, Urumqi, China.
Hong
H
Zheng
London Health Sciences Centre, London, Canada.
Mackenzie
M
Quantz
Cleveland Clinic, Cleveland, OH.
Jean-Pierre
JP
Yared
West China Hospital, Sichuan University, Chengdu, China.
Hai
H
Yu
Centre Hospitalier de l'Université de Montréal, Montréal, Canada.
Nicolas
N
Noiseux
Population Health Research Institute, McMaster University/Hamilton Health Sciences, Hamilton, Canada.
Salim
S
Yusuf
D000368:Aged; D000369:Aged, 80 and over; D006348:Cardiac Surgical Procedures; D002423:Cause of Death / Q000639:trends; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D014943:Global Health; D005938:Glucocorticoids / Q000008:administration & dosage; D006331:Heart Diseases / Q000601:surgery*; D006801:Humans; D015994:Incidence; D007275:Injections, Intravenous; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage*; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D011300:Preoperative Care / Q000379:methods*; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
D005938:Glucocorticoids; D008775:Methylprednisolone