A clinical trial comparing how well two solutions protect the heart during heart surgery in childre

Not Applicable

• Conditions: Cardiac surgery; Circulatory System

• Registration Number: ISRCTN13638147
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-28
• Last Update Posted: 9 September 2024
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Children (<16 years) undergoing cardiac surgery on cardiopulmonary bypass with cardioplegic arrest

Exclusion Criteria

Current exclusion criteria as of 14/03/2024:

1. Predicted cross-clamp time <30 minutes (e.g. atrial septal defect, atrial septectomy, sub-aortic stenosis) at the discretion of the Consultant surgeon
2. Known contraindication to one of the constituents of either cardioplegia solution (e.g. lidocaine/procaine hypersensitivity/allergy) or its method of delivery, including temperature (e.g. haemoglobinopathy including sickle cell disease, cold agglutinins)
3. Ventricular assist device (VAD) insertion/explant or transplantation
4. Pre-operative inotropic support or extracorporeal life support (ECLS)
5. Previous cardiac surgery with cardioplegic arrest within the last 30 days
6. Previous enrolment in the DESTINY trial
7. Emergency surgery
8. Parent/guardian declines consent
9. Weight at the time of surgery >50kg

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Previous exclusion criteria:

1. Predicted cross-clamp time <30 minutes (e.g. atrial septal defect, atrial septectomy, sub-aortic stenosis) at the discretion of the Consultant surgeon
2. Known contraindication to one of the constituents of either cardioplegia solution (e.g. lidocaine/procaine hypersensitivity/allergy) or its method of delivery, including temperature (e.g. haemoglobinopathy including sickle cell disease, cold agglutinins)
3. Ventricular assist device (VAD) insertion/explant or transplantation
4. Pre-operative inotropic support or extracorporeal life support (ECLS)
5. Previous cardiac surgery with cardioplegic arrest within the last 30 days
6. Emergency surgery
7. Parent/guardian declines consent

(added 15/03/2023)
8. Weight at the time of surgery >50kg
9. Previous enrolment in the DESTINY trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in 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).