Steroids In caRdiac Surgery Trial (SIRS Trial)

• Status: Unknown status
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

SIRS trial is a large simple study in which high-risk patients undergoing cardiac surgery requiring the use of cardiopulmonary bypass (CPB) are randomly allocated to receive a pulse dose of Methylprednisolone or a matching placebo. Cardiopulmonary bypass initiates a systemic inflammatory response that facilitates development of post-operative complications. SIRS will confirm or deny the potential clinical benefits of suppressing this response through the use of systemic steroids. Specifically, does 250 mg of intravenous Methylprednisolone given twice, once on anesthetic induction and again on CPB initiation, result in improved early survival and less myocardial infarction in high-risk cardiac surgery patients requiring CPB?

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. Age greater than 18 years

2. Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures)

3. Must have a EuroSCORE ≥ 6

4. Provide written informed consent

NOTE: For participating sites in India, China and Hong Kong, the following eligibility criteria will be applied:

1. Age greater than 18 years

2. Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures)

3. Must have at least one of the following:

1. EuroSCORE greater than or equal to 4 and undergoing valvular surgery

2. EuroSCORE greater than or equal to 6 and undergoing any other cardiac surgery procedure (i.e. CABG, Aorta)

4. Provide written informed consent

Exclusion Criteria:

1. Use of systemic corticosteroids

2. History of bacterial or fungal infection in last 30 days

3. Allergy/intolerance to corticosteroids

4. Will receive Aprotinin

5. Previous participation in study