Health Condition 1: null- Cardiopulmonary Bypass Surgery
Conditions
Interventions
Intervention1: Inj.Methylprednisolone: 500mg. in division of 250mg twice during anesthesia procedure prior to surgery and route of administration will be intravenous.
Control Intervention1: Placebo: 5
Sponsors
Population Health Research Institute McMaster UniversityHamilton
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality at 30 days.Timepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Greece, Hungary, India, Ireland, Italy, Spain, United Kingdom, United States of America
Contacts
Public ContactDr G Karthikeyen
AIIMS
Outcome results
None listed