Cardiac disease/coronary surgery Circulatory System Heart failure
Conditions
Interventions
Eligible patients undergoing coronary artery bypass grafting (CABG) or aortic valve replacement (AVR) with cardiopulmonary bypass (CPB) and who consent to participate will be randomly allocated to eit
Sponsors
University Hospitals Bristol NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion 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
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: 2. Concomitant CABG/AVR procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure(s) as of 01/02/2011: The primary outcome will be myocardial injury, assessed by measuring myocardial Troponin T in serum from blood samples collected pre-operatively and at 1, 6, 12, 24 and 48 hours post chest closure. Previous primary outcome measure(s): Myocardial injury, assessed by measuring myocardial Troponin T in serum from blood samples collected pre-operatively and 1, 6, 12, 24 and 48 hours post cross-clamp release | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure(s) as of 01/02/2011: 1. Myocardial ischaemic stress assessed using biopsies taken from left and right ventricles immediately prior to aortic cross-clamping and 10 minutes post chest closure. Gene expression and cellular changes associated with stress and injury signalling pathways will be measured from metabolite/RNA extracts. 2. Systemic metabolic stress, assessed by measuring lactate in blood samples collected pre-operatively, 10 minutes after aortic chest closure and 1, 6, 12, 24 and 48 hours post chest closure. 3. Blood pH, measured using each sample collected for (b). 4. Renal function, assessed by measuring creatinine in serum from blood samples collected pre-operatively and 1, 6, 12, 24 and 48 hours post chest closure. 5. The concentration of plasma propofol, measured in blood samples collected immediately before aortic cross-clamping, once during cardioplegia (after blood/cardioplegia mixing) and 10 minutes post cross-clamp release. Blood will be taken from the cardioplegia/bypass circuit. 6. Length of intensive care unit (ICU)/high dependency unit (HDU) stay. 7. Clinical outcomes and serious adverse events, i.e. serious post-operative complications (e.g. myocardial infarction, permanent stroke, renal failure defined as new need for haemodialysis) and death from any cause. 8. Patient health status, monitored using specialist questionnaires administered pre-operatively and 3 months post-operatively. CABG patients will be asked to complete the Coronary Revascularisation Outcome Questionnaire (CROQ) and AVR patients will be asked to complete the Minnesota Living with Heart Failure (MLHF) Questionnaire. The EQ-5D™ health questionnaire will also be administered to all patients. Previous secondary outcome measure(s): 1. Myocardial ischaemic stress assessed using biopsies taken from left and right ventricles immediately prior to aortic cross-clamping and 10 minutes after cross-clamp release. Gene expression and cellular change | — |
Countries
United Kingdom
Outcome results
None listed