Congenital malformations of cardiac chambers and connections Surgery
Conditions
Interventions
Eligible patients requiring congenital heart operations who give consent will be randomised to receive either warm blood cardioplegia or cold blood cardioplegia during their cardiac surgery. Clinical
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing a congenital heart operation requiring CPB and cardioplegic arrest at the BRHC
Exclusion criteria
Exclusion criteria: 1. Patient weighing < 3 kg 2. Patient requires an emergency operation (patient with haemodynamic instability who require immediate surgical intervention defined as operation within 24 hours of admission) 3. Patient requires secundum atrial septal defect repair (ASD) as an isolated procedure 4. Patient judged pre-operatively by surgeon to require deep hypothermic circulatory arrest (e.g. aortic arch repair, repair of total anomalous pulmonary venous drainage (TAPVD), Norwood procedure) 5. Patient judged pre-operatively by the surgeon to require deep hypothermic CPB 6. Patient judged by the surgeon pre-operatively to be too complex. This could be procedure related or patient related (e.g. complex tailor made surgery; necrotising enterocolitis; pre-operative brain haemorrhage; or generalised bleeding state/ongoing major bleeding) 7. Patient of consenting/assenting age lacking capacity to consent/assent 8. Patient under the care of social services and/or parent/guardian unavailable for consent For the sub-study, the following additional exclusion criteria will apply: 9. Patient aged < 4 months 10. Patient weighing < 6 kg 11. Patient has contraindication for urethral catheterisation due to urethral obstruction or haemorrhage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Troponin T (cTnT) levels over the first 48 postoperative hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/03/2020: 1. Cardiac function, assessed by measuring cardiac output and cardiac index. Central venous saturations (ScvO2), arterial saturations, base deficit & blood lactate will also be recorded as indirect measures of cardiac index. Central venous saturations (ScvO2), arterial saturations, base deficit and blood lactate recorded as indirect measures of cardiac index up to 48 hours postoperatively 2. Routine blood gas and blood sample/test results measured before, during and after surgery (up to 48 hours postoperatively). Results collected will include pH, PO2, PCO2, base excess and lactate from blood gases and serum creatinine and urea nitrogen (measures of renal function), c-reactive protein (CRP), haemoglobin (Hb), haematocrit (Hct), white cell count (WCC) and alanine aminotransferase (ALT) from blood samples. 3. Renal function measured by urinary albumin, urinary creatinine, retinal binding protein (RBP), N- acetyl- ß-glucosaminidase (NAG) and neutrophil gelatinase-associated lipocalin (n-GAL) in urine samples, measured before surgery and at 4 hours, 24 hours and 48 hours postoperatively 4. Cardiac and electrical activity on removal off cross clamp and chest closure (arrhythmias including; atrial fibrillation/flutter, ventricular tachycardia, ventricular fibrillation, nodal, junctional ectopic tachycardia (JET) or AV block) 5. Postoperative blood loss in the first 12 hours 6. New onset of arrhythmia post-operatively (either supraventricular tachycardia/atrial fibrillation or ventricular fibrillation/ventricular tachycardia, JET or heart block) 7. Vasoactive-inotrope score (VIS) over the first 48 hours after admission to PICU 8. Intubation time 9. Time from return from theatre until fit for discharge to the ward/high dependency unit (HDU) from the paediatric intensive care unit | — |
Countries
England, United Kingdom
Outcome results
None listed