A clinical trial to study the use of Remote Ischemic Preconditioning procedure in cardiac surgery patients
Phase 3
- Conditions
- Health Condition 1: null- Patient undergoing cardiac surgery
- Registration Number
- CTRI/2011/05/001715
- Lead Sponsor
- Population Health Research Institute PHRI at McMaster UniversityHamilton Health Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
Inclusion Criteria
1) Age more then or equal to 18 years
2) Undergoing cardiac surgery
3) Standard Euro score more then or equal to 6
and
4) Provide written informed consent to participate.
Exclusion Criteria
1) Requires an intra- aortic ballon pump preoperatively
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) recruitment rate per centre<br>2) follow-up completeness at 30 days and 6 months after surgeryTimepoint: 30 days and 6 months
- Secondary Outcome Measures
Name Time Method Incidence of death from any cause at 30 days after surgeryTimepoint: 30 days and 6 months;Incidence of documented myocardial infarction at 30 days after surgeryTimepoint: 30 days and 6 months;Incidence of documented stroke at 30 days after surgeryTimepoint: 30 days and 6 months;Incidence of new dialysis required within 30 days after surgeryTimepoint: 30 days and 6 months;Number of days in the intensive care unit and in hospital after surgeryTimepoint: 30 days and 6 months;Peak change in CK-MB in the first 24 hours after surgery <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 30 days and 6 months;Peak change in serum creatinine in the first 4 days after surgeryTimepoint: 30 days and 6 months