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

NCT05176782 | Unknown Early Phase 1

• 1 other identifier: FAMSU R 206/2021
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• • Vasoactive-Inotropic Score

  Calculate the doses of vasoactive drugs used

  From time of separation of cardioplumonary bypass till 24 hours post operative

Study Arms (2)

Group A (HTK cardioplegia)

ACTIVE COMPARATOR

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

Drug: HTK cardioplegia

Group B ( Cold Cardioplegia)

ACTIVE COMPARATOR

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.

Drug: Cold Cadioplegia

Interventions

HTK cardioplegia DRUG

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

Group A (HTK cardioplegia)

Cold Cadioplegia DRUG

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.

Group B ( Cold Cardioplegia)

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Samar Soliman

Cairo, Nasr City, 11511, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: December 15, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 15, 2022
• Last Updated: January 4, 2022

Record last verified: 2022-01

Locations

EG (1)