Status:
UNKNOWN
Steroids In caRdiac Surgery Trial (SIRS Trial)
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Cardiac Surgical Procedures
Cardiopulmonary Bypass
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 Methylpred...
Detailed Description
Cardiopulmonary bypass (CPB) is a commonly performed surgical procedure with over 500,000 per year in North America. CPB initiates a systemic inflammatory response characterized by both cell and prote...
Eligibility Criteria
Inclusion
- Age greater than 18 years
- Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures)
- Must have a EuroSCORE ≥ 6
- Provide written informed consent
- NOTE: For participating sites in India, China and Hong Kong, the following eligibility criteria will be applied:
- Age greater than 18 years
- Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures)
- Must have at least one of the following:
- EuroSCORE greater than or equal to 4 and undergoing valvular surgery
- EuroSCORE greater than or equal to 6 and undergoing any other cardiac surgery procedure (i.e. CABG, Aorta)
- Provide written informed consent
Exclusion
- Use of systemic corticosteroids
- History of bacterial or fungal infection in last 30 days
- Allergy/intolerance to corticosteroids
- Will receive Aprotinin
- Previous participation in study
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
7507 Patients enrolled
Trial Details
Trial ID
NCT00427388
Start Date
June 1 2007
End Date
August 1 2014
Last Update
August 4 2014
Active Locations (1)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2