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

Early Phase 1

• Conditions: Anesthesia
• Interventions: Drug: HTK cardioplegia; Drug: Cold Cadioplegia

• Registration Number: NCT05176782
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Study First Submitted: 2021-12-15
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-03
• Last Update Submitted: 2022-01-03
• Study First Posted: 2022-01-04
• Last Update Posted: 2022-01-04
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (HTK cardioplegia)	HTK cardioplegia	will receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula.
Group B ( Cold Cardioplegia)	Cold Cadioplegia	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.

Primary Outcome Measures

Name	Time	Method
• Vasoactive-Inotropic Score	From time of separation of cardioplumonary bypass till 24 hours post operative	Calculate the doses of vasoactive drugs used

Trial Locations

Locations (1)

Samar Soliman; 🇪🇬 Cairo, Nasr City, Egypt