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NCT05176782 Clinical Trial

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

Anesthesia Clinical Trial

Official title:
Randomized Clinical Trial: Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05176782
Other study ID # FAMSU R 206/2021
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date December 15, 2021
Est. completion date March 15, 2022

Study information
Verified date January 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 52
Est. completion date March 15, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Months to 5 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• HTK cardioplegia
will receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula.
• Cold Cadioplegia
as the 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.

Locations
Country Name City State
Egypt Samar Soliman Cairo Nasr City

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary • Vasoactive-Inotropic Score Calculate the doses of vasoactive drugs used From time of separation of cardioplumonary bypass till 24 hours post operative
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