SIRS Steroids In caRdiac Surgery Trial - SIRS

• Conditions: Study Objective(s) To determine whether high-risk patients undergoing cardiac surgery requiring CPB derive benefit from perioperative steroids. Study Design Multicentre, International, randomized, double-blind placebo-controlled trial of high-risk adult patients undergoing cardiopulmonary bypass.

• Registration Number: EUCTR2011-000591-34-IE
• Lead Sponsor: Mater University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 3750

Inclusion Criteria

1. Age = 18 years
2. Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures)
3. EuroScore greater than or equal to 6
4. Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Use of systemic steroids or will undergo planned systemic steroid therapy in the immediate postoperative period (e.g. cardiac transplantation)
2. History of bacterial or fungal infection in the last 30 days
3. Allergy or intolerance to corticosteroids
4. Receiving Aprotinin
5. Previous participation in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified