Cardiac surgery Circulatory System
Conditions
Interventions
The trial interventions are either del Nido cardioplegia (experimental arm) or St. Thomas’ blood cardioplegia (control arm). del Nido cardioplegia is administered in a 1:4 blood:crystalloid preparatio
and at 5 timepoints after the operation, at 3, 6, 9, 12 and 24 hours after surgery.
Following surgery, the child will be transferred to the Paediatric Intensive Care Unit and will be closely monitore
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
0 Years to 16 Years
Inclusion criteria
Inclusion criteria: Children (<16 years) undergoing cardiac surgery on cardiopulmonary bypass with cardioplegic arrest
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 18/03/2025: 1. Predicted cross-clamp time 50 kg _____ Previous exclusion criteria as of 14/03/2024: 1. Predicted cross-clamp time 50 kg _____ Previous exclusion criteria: 1. Predicted cross-clamp time 50 kg 9. Previous enrolment in the DESTINY trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the time-concentration curve (AUC) for plasma high-sensitivity troponin-I (µg.h/L) in the first 24 hours after the index aortic cross-clamp release (reperfusion). | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/03/2024: 1. Low cardiac output syndrome (LCOS) defined as either of the following: Vasoactive Inotrope Score (VIS) =15, or major cardiac event (cardiac arrest, ECLS or death) in the first 48 hours after reperfusion 2. Duration of mechanical ventilation (hours), defined as the number of hours from termination of index CPB to extubation 3. Length of postoperative stay on Paediatric Intensive Care (hours), defined as number of hours from admission to PICU from theatre following index procedure to discharge from PICU 4. Maximum VIS by thresholds: =10, =15 and =20 in the first 48 hours after reperfusion 5. Total VIS in the first 4 hours after PICU admission following the index procedure (score) 6. Arterial lactate (mmol/L) in the first 12 hours after reperfusion 7. Omega, determined by [SaO2]/[SaO2-ScvO2] in the first 12 hours after reperfusion 8. Total aortic cross-clamp time (mins) during the index procedure 9. Total volume of cardioplegia given (ml) during the index procedure 10. Need for internal defibrillation during reperfusion during the index procedure 11. Delayed sternal closure, incidence and duration (days) following the index procedure 12. Unplanned reoperation, including chest re-opening on PICU, following the index procedure 13. Need for new renal replacement therapy following the index procedure 14. Lowest estimated glomerular filtration rate (eGFR), calculated using the bedside Schwartz equation and the peak postoperative creatinine on routine monitoring during the first 7 days following the index procedure (ml/min/1.73m²), and according to the paediatric RIFLE categories 15. Length of postoperative stay in the hospital (days), defined as number of days from day of the index procedure to discharge from hospital or death, whichever is sooner 16. 30-day survival following the index procedure _____ Previous secondary outcome measures: 1. Low cardiac output syndrome (LCOS) defined as either of the following: Va | — |
Countries
England, United Kingdom
Outcome results
None listed