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comparision of 2 different solutions used to arrest heart

Comparison of de Nido cardioplegia solution with Histidine-Tryptophan-Ketoglutarate cardioplegia solution in pediatric patients undergoing Arterial Switch Operations: A Prospective Randomized Controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021408
Enrollment
80
Registered
2019-09-25
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: Q203- Discordant ventriculoarterial connection

Interventions

Intervention1: HTK cardioplegia solution: Dose:30ml/kg Frequency : One dose through Route :into aorta Duration: only once for entire duration of surgery Control Intervention1: del Nido cardioplegia

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: children in the above mentioned age group undergoing elective Arterial Switch Operations

Exclusion criteria

Exclusion criteria: 1. Patients for which consent not provided by parents for inclusion in study. 2. Patients with other associated illnesses 3. Preoperative neurological defects

Design outcomes

Primary

MeasureTime frame
a) Cardiac index with the use of the 2 cardioplegia solutions in operation theatre after coming off CPBTimepoint: in ICU after 4hours, 12 hours, 24 hours and 48 hours.

Secondary

MeasureTime frame
a)Diffrences in inotropic scores in two group at 24,48,72 and 96 hours. bTo assess and compare the levels of inflammatory markers before and after cardiopulmonary bypass with the use of these cardioplegia solution. d)To assess and compare the ultra structural changes in the myocardium after cardioplegia. Timepoint: post op 24hours, 48 hours, 72 hours, 96hours

Countries

India

Contacts

Public ContactDr Srikant sharma

AIIMS

sachintalwar@hotmail.com9868398136

Outcome results

None listed

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