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Am Heart J. 2014 May;167(5):660-5. doi: 10.1016/j.ahj.2014.01.018. Epub 2014 Mar 1.

Rationale and design of the steroids in cardiac surgery trial.

Author information

1
Population Health Research Institute, McMaster University/Hamilton Health Sciences, Hamilton, Canada. Electronic address: Richard.Whitlock@phri.ca.
2
Population Health Research Institute, McMaster University/Hamilton Health Sciences, Hamilton, Canada.
3
University of Bari Aldo Moro, Bari, Italy.
4
West China Hospital, Sichuan University, Chengdu, China.
5
Department of Outcomes Research, Cleveland Clinic, Cleveland, OH.
6
Princess Alexandra Hospital, Woolloongabba, Australia.
7
Fundación Cardio Infantil-Instituto de Cardiología, Bogotá, Colombia.
8
All India Institute of Medical Sciences, New Delhi, India.
9
Institut d'Investigació Biomèdica Sant Pau-CIBERESP, Barcelona, Spain.
10
Divisão de Pesquisa, Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil.
11
Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
12
First Teaching Hospital of Xinjiang Medical University, Urumqi, China.
13
London Health Sciences Centre, London, Canada.
14
Cleveland Clinic, Cleveland, OH.
15
Centre Hospitalier de l'Université de Montréal, Montréal, Canada.

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00427388.

PMID:
24766975
DOI:
10.1016/j.ahj.2014.01.018
[Indexed for MEDLINE]

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