se of Steroids in cardiac surgery
Phase 3
- Conditions
- Health Condition 1: null- Cardiopulmonary Bypass Surgery
- Registration Number
- CTRI/2011/10/002066
- Lead Sponsor
- Population Health Research Institute McMaster UniversityHamilton
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 7500
Inclusion Criteria
1.Age 18 years
2.Reqire CPB for any cardiac surgical procedure (such as CABG,Valve,Arota or combined procedures)
3.Euroscore greater than or equal 6
4.Written informed consent
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.Receving Aprotinin
5.Previous participation in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All cause mortality at 30 days.Timepoint: 30 days
- Secondary Outcome Measures
Name Time Method Efficacy Outcome- All cause mortality at 6 months,new onset atrial fibrilation,transfusion reqirements,bleeding,length of ICU stay and hospital stay.Timepoint: 6 months;Safety outcome- Infection.delirium,stroke,wound complication,GI hemorrhage,GI perforation,postoperative insulin use and peak blood glucose during the first 24 hours after surgery.Timepoint: 24 hours after surgery;Significant Myocardial injury or death at 30 daysTimepoint: 30 days