ISRCTN84968882
Completed
Phase 4
A single-centre randomised controlled trial of propofol cardioplegia on blood and myocardial biomarkers of stress and injury in patients having isolated coronary artery bypass grafting (CABG) or aortic valve replacement (AVR) using cardiopulmonary bypass (CPB)
niversity Hospitals Bristol NHS Foundation Trust (UK)0 sites96 target enrollmentNovember 11, 2009
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospitals Bristol NHS Foundation Trust (UK)
- Enrollment
- 96
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25004932
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 01/02/2011:
- •1\. Male or female
- •2\. Age \=18 to \=80 years
- •3\. Having elective or urgent CABG or AVR with CPB at the BHI
- •4\. Able to give full informed consent for the study
- •Previous inclusion criteria:
- •1\. Male or female
- •2\. Aged greater than or equal to 16 years to less than or equal to 80 years
- •3\. Having elective or urgent CABG or AVR with CPB at the Bristol Heart Institute (BHI)
- •4\. Able to give full informed consent for the study
Exclusion Criteria
- •Current inclusion criteria as of 01/02/2011:
- •1\. Previous cardiac surgery
- •2\. Combined CABG and AVR
- •3\. Emergency or salvage operation
- •4\. Chronic renal failure requiring dialysis
- •5\. Current congestive heart failure
- •6\. Left ventricular ejection fraction less than 30% (i.e. poor LV function)
- •7\. Allergy to peanuts, eggs, egg products, soybeans or soy products
- •8\. Already participating in another clinical (interventional) study
- •Previous inclusion criteria:
Outcomes
Primary Outcomes
Not specified
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