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Population Health. Research Institute. Steroids In caRdiac Surgery (SIRS) Trial. Population Health Research Institute Hamilton Health Sciences/McMaster University Hamilton, Canada. SIRS was funded by grants from the Canadian Institutes of Health Research (CIHR)

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Population Health

Research Institute

Steroids In caRdiac Surgery (SIRS) Trial

Population Health Research Institute

Hamilton Health Sciences/McMaster University

Hamilton, Canada

SIRS was funded by grants from the Canadian Institutes of Health Research (CIHR)

and the Canadian Network and Centre for Trials Internationally(CANNeCTIN)

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Trial Flow Diagram

Randomized (n = 7,507)

Allocated to steroid* (n = 3,755)

Allocated to Placebo (n = 3,752)

Lost to follow-up (n = 1)

Did not receive study drug (n = 105)

Lost to follow-up (n = 0)

Did not receive study drug (n = 106)

Analyzed by intention-to-treat (n = 3,752)

Complete follow-up data (n = 3,751)

Analyzed by intention-to-treat (n = 3,755)

Complete follow-up data (n = 3,754)

*500 mg IV Methylprednisolone given intra-operatively

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Conclusion

Methylprednisolone does not reduce death or major morbidity at 30 days for high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass.

Methylprednisolone increases the risk of early post-operative myocardial infarction, defined by CK-MB biomarker release.

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Implications

Methylprednisolone should not be administered prophylactically to high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass.

Further work is necessary to understand the mechanism of steroid-driven myocardial infarction.

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