Clinical trial
Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery
Name
IRB 2016-08 Custodiol Study
Description
Cardioplegic arrest is an essential part of cardiac surgery which aims to allow myocardial preservation and minimise myocardial swelling ,while providing a motionless and bloodless field ,.Blood cardioplegia has proven its efficacy for several decades and surgeons are still preferring to use it for myocardial protection of paediatric cardiac surgery ,although it is thought to be more time consuming since it is given with interrupted doses, . Even when advancement has came along the field of myocardial protection and cardioplegia solutions with the introduction of Bretschneider Histidine-Tryptophan-Ketoglutarate solution ,custodiol ,in 1970 ,which is given as a single dose and believed to be convenient, simple to deliver , and less time consuming . Many Surgeons haven't change their practice possibly due to paucity of studies comparing cardioplegia solutions in paediatric cardiac surgery and conflicting reports regarding the superiority of different cardioplegia solution.The investigators aim to provide evidence that will help paediatric cardiac surgeons to choose the optimal solution for their practice .
Trial arms
Trial start
2016-03-16
Estimated PCD
2018-03-29
Trial end
2018-03-29
Status
Completed
Phase
Early phase I
Treatment
Custodiol Solution
After cross clamping patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.
Arms:
custodiol group
Other names:
htk
Blood cardioplegia
After cross clamping patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg.
Arms:
blood cardioplegia group
Size
49
Primary endpoint
Mortality (yes/no)
up to 30 days
ICU stay (days)
up to 90 days (length of ICU stay required after the operative procedure recorded by days until discharge or death)
Arrhythmia (yes/no)
up to 48 hours
Eligibility criteria
Inclusion Criteria:
* All paediatric patients referred to our hospital which will undergo open cardiac repair with cardiopulmonary bypass and cardioplegic arrest .
Exclusion Criteria:
* All emergency procedure( require immediate surgery)
* Cases that don't require use of cardioplegia .
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Randomisation :\n\nComputer generated randomisation into two groups based on cardioplegia solution .\n\nif randomised to blood patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg.\n\nif randomised to custodial patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.", 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Blinding :\n\nSurgeons will know the type of cardioplegia in the OR while other assessor will be blinded .', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}
Updated at
2023-04-13
1 organization