completed

SIRS was a multicentre, international, randomized, controlled, double-blind placebo-controlled trial of high-risk adult patients undergoing cardiopulmonary bypass.

Patients were 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.

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.

Study Type

Interventional - Drug

Study Design

Randomized, double-blind treatment, placebo control, parallel group

NO. of Countries

18

NO. of Sites

86

NO. of Participants

7507

Study Period

2007-2014

Sponsor

PHRI

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