Reperfusion injury of the heart following coronary artery bypass grafting (CABG) surgery Circulatory System
Conditions
Interventions
Study patients will be randomly allocated in a 1:1:1 ratio to one of the following:
Placebo: Blood cardioplegia with sham supplementation (normal saline 0.9% weight/volume sodium chloride, NaCl),
Pro
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years 2. Having elective or urgent isolated CABG with CPB 3. Ability to give informed consent Women only: 4. Negative pregnancy test, or be surgically or post-menopausal for >12 months
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 20/05/2020: 1. Previous cardiac surgery 2. Planned concomitant procedure 3. Emergency or salvage operation 4. Long-term steroid therapy (taking tablets on a daily basis for at least 1 month prior to surgery) 5. Pre-operative estimated glomerular filtration rate = 30 ml/min/1.73m2 6. Current congestive heart failure 7. Left ventricular (LV) ejection fraction 500 ng/l (or cTnI level >600 ng/l) in the last 4 days (prior to eligibility check) Women only: 13. Breast feeding Previous participant exclusion criteria: 1. Previous cardiac surgery 2. Planned concomitant procedure 3. Emergency or salvage operation 4. Long-term steroid therapy 5. Pre-operative estimated glomerular filtration rate < = 60 mls/min/1.73m2 6. Current congestive heart failure 7. Left ventricular (LV) ejection fraction < 30% (i.e. poor LV function) 8. Allergy to peanuts, eggs, egg products, soybeans or soy products 9. Already participating in another interventional clinical study 10. Prisoners Women only: 11. Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial injury, assessed by serial measurements of cTnT in serum from blood samples collected pre-operatively and during the first 48-hours post chest closure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 06/06/2023: 1. Systemic metabolic stress as measured by blood lactate at pre-op, 10 mins post cross clamp, 1, 6, 12, 24, 48 hours post chest closure 2. Renal function, as measured by creatinine in serum at pre-op, 1, 6, 12, 24, 48 hours post chest closure 3. Markers of Inflammation and oxidative stress as measured by tumour necrosis factor (TNF)-alpha, interleukin (IL)-10, IL-8, IL-6 and myeloperoxidase (MPO) in serum (Bristol cohort only) at pre-op, 1, 6, 12, 24, 48 hours post chest closure 4. Blood pH at pre-op, 1, 6, 12, 24, 48 hours post chest closure 5. Length of intensive care unit (ICU) stay 6. Length of postoperative hospital stay 7. Clinical outcomes and serious adverse events, i.e. serious post-operative complications (e.g. MI, permanent stroke, acute kidney injury) and death from any cause 8. QoL measured using the Coronary Revascularisation Outcome Questionnaire (CROQ) and the EQ-5D-5L questionnaire at baseline, 3 months and 12 months _____ Previous secondary outcome measures as of 27/05/2022: 1. Systemic metabolic stress as measured by blood lactate at pre-op, 10 mins post cross clamp, 1, 6, 12, 24, 48 hours post chest closure 2. Renal function, as measured by creatinine in serum at pre-op, 1, 6, 12, 24, 48 hours post chest closure 3. Markers of Inflammation and oxidative stress as measured by tumour necrosis factor (TNF)-alpha, interleukin (IL)-10, IL-8, IL-6 and myeloperoxidase (MPO) in serum (Bristol cohort only) at pre-op, 1, 6, 12, 24, 48 hours post chest closure 4. Blood pH at pre-op, 1, 6, 12, 24, 48 hours post chest closure 5. Investigate the association between cTnT and circulating level of cardiac-released microRNA-1 and exosomal microRNA-1 content at pre-op, 1, 6, 12, 24, 48 hours post chest closure (Bristol cohort only) 6. Examine whether the association between cTnT and microRNA and exosomal microRNA-1 content differs between groups (i.e. differs with the propofol supplementation received) at pr | — |
Countries
England, United Kingdom
Contacts
Public ContactBeth Fitzgerald
Outcome results
None listed