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Comparison of Two different compositions of solution used to arrest the heart during cardiac surgery in children

Comparison of Plasmalyte-A based Delnido cardioplegia solution with Plain Ringer based Delnido cardioplegia solution in pediatric patients undergoing open heart surgeries: A Double Blind Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010464
Enrollment
80
Registered
2017-11-13
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: Q213- Tetralogy of Fallot

Interventions

Intervention1: Plain Ringer based Delnido cardioplegia solution: in pediatric patients undergoing open heart surgeries at a dose of 20ml/kg body weight mixed with patients blood in 3:1 ratio respectiv

Sponsors

Director
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: children in the above mentioned age group undergoing elective repair of complex cyanotic congenital heart defect with anticipated aortic cross clamp times of greater than 45 minutes will be recruited in this study.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery 2. Patients with associated illnesses 3. Preoperative neurological defects 4. Other simple congenital defects and syndromes which have less than 45 minutes clamp time

Design outcomes

Primary

MeasureTime frame
To determine whether the 2 types of cardioplegia solutions: Plasmalyte â??A based Del Nido or plain Ringer based Del Nido , similar in terms of surrogates of myocardial protection and morbidity and mortality.Timepoint: 48 hours

Secondary

MeasureTime frame
1)To assess cardiac enzyme release and/or presence of low cardiac output syndrome clinically and ionotropic score in the immediate postoperative period of 48 hours. 2)To compare the Cardiac Index of the 2 groups in the 48 hours post operative period. 3)To assess and compare for the presence of rhythm disturbances.Timepoint: 48 hours

Countries

India

Contacts

Public ContactDr Sachin Talwar

AIIMS,NEW DELHI.

sachintalwar@hotmail.com9868398136

Outcome results

None listed

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