Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair

Ain Shams University

Status and phase: Unknown; Early Phase 1

Conditions: Anesthesia

Treatments: Drug: Cold Cadioplegia; Drug: HTK cardioplegia

Study type: Interventional

Funder types: Other

Identifiers

NCT05176782

FAMSU R 206/2021

Details and patient eligibility

About

Randomized clinical trial: comparison between Histidine-tryptophan-ketoglutarate cardioplegia and cold blood cardioplegia for myocardial protection for Fallot tetralogy patients undergoing total repair This study aims to compare HTK cardioplegic solution and cold blood cardioplegia to provide optimal myocardial protection for a patient with tetralogy of Fallot planned for total repair.

Enrollment: 52 estimated patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients with tetralogy of Fallot spectrum.
• Sex (males and females)
• Age 6 months- 5 years.

Exclusion criteria

• Persistent left SVC draining in the coronary sinus.
• Mental or neurologic disorders.
• Preoperative critically ill patients.
• Parents or legal guardian refusal.
• Fallot repair with transannular patch( as it will affect on the RV function as a single agent after reperfusion)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups

Group A (HTK cardioplegia)

Active Comparator group

Description:

will receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula.

Treatment:

Drug: HTK cardioplegia

Group B ( Cold Cardioplegia)

Active Comparator group

Description:

will receive group cold Blood Cardioplegia in volume 20mL/kg given by antegrade route through an aortic route cannula and repeated 10mL/kg/dose every 25minutes at 8-12°C for maintenance. This technique considered the standard management in this age.

Treatment:

Drug: Cold Cadioplegia