Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

March 16, 2016

Primary Completion Date

March 29, 2018

Study Completion Date

March 29, 2018

Conditions
Congenital Heart Disease
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

40047

King Faisal Specialist Hospital and Research Centre, Jeddah

All Listed Sponsors
lead

King Faisal Specialist Hospital & Research Center

OTHER

NCT03082716 - Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery | Biotech Hunter | Biotech Hunter