Comparison of 2 types of cardioplegia(solutions that stop the heart momentarily during cardiac surgery) in pediatric patient undergoing heart surgeries.

Comparison of DelNido and Custodial cardioplegia solutions in pediatric patients undergoing open heart surgeries: A prospective randomized control trial - DelC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/07/009067

Enrollment

100

Registered

2017-07-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Congenital cyanotic heart disease patients, whose estimated aortic cross clamp time during surgery is more than 45 mins

Interventions

Intervention1: DelNido Cardioplegia: One group of patients are given this cardioplegia post application of cross clamp. Control Intervention1: Custodial Cardioplegia: Another group of patients are giv

Eligibility

Inclusion criteria

Inclusion criteria: All elective repair of complex cyanotic congenital heart defect with anticipated aortic cross clamp times of greater than 45 minutes.

Exclusion criteria

Exclusion criteria: 1. emergency surgery, 2. patients with associated illnesses 3. preoperative neurological defects 4. other simple congenital defects and syndromes.

Design outcomes

Primary

Measure	Time frame
To compare the cardiac index post CPB with the use of the 2 cardiaplegia solutions.Timepoint: In operation theatre after coming off bypass, in icu 4hrs, 12 hrs, 24 hrs and 48 hrs after shifting from ot.	—

Secondary

Measure	Time frame
To assess and compare rhythm disturbances i.e ventricular tachycardia following cross clamp release or post operative supraventricular tachycardia.Timepoint: Till the patient is in ICU;To assess and compare the duration of mechanical ventilation required post surgery with the use of 2 cardioplegia solutionTimepoint: Till the patient is in ICU;To assess and compare the levels of inflammatory markers before and after CPB.Timepoint: Till 48 hrs post operation.;To assess and compare the surrogates of myocardial protection in the form of cardiac enzyme release and or presence of low cardiac output syndrome or use of ionotropes.Timepoint: Till the patient is discharged after operation from hospital;To assess ans compare the ultrastructural changes in the myocardium after cardioplegia.Timepoint: sample taken during surgery	—

Measure

Time frame

To assess and compare rhythm disturbances i.e ventricular tachycardia following cross clamp release or post operative supraventricular tachycardia.Timepoint: Till the patient is in ICU;To assess and compare the duration of mechanical ventilation required post surgery with the use of 2 cardioplegia solutionTimepoint: Till the patient is in ICU;To assess and compare the levels of inflammatory markers before and after CPB.Timepoint: Till 48 hrs post operation.;To assess and compare the surrogates of myocardial protection in the form of cardiac enzyme release and or presence of low cardiac output syndrome or use of ionotropes.Timepoint: Till the patient is discharged after operation from hospital;To assess ans compare the ultrastructural changes in the myocardium after cardioplegia.Timepoint: sample taken during surgery

—

Countries

India

Contacts

Public ContactSujoy Chatterjee

All India Institute of Medical Sceinces

sachintalwar@hotmail.com986939836

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026