Intermittent antegrade warm blood versus cold blood cardioplegia in children undergoing open heart surgery

Not Applicable

Completed

• Conditions: Congenital malformations of cardiac chambers and connections; Surgery

• Registration Number: ISRCTN13467772
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33055113/ protocol (added 22/10/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36799559/ (added 20/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-05
• Study Completion: 2021-09-30
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Patients undergoing a congenital heart operation requiring CPB and cardioplegic arrest at the BRHC

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Troponin T (cTnT) levels over the first 48 postoperative hours