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

NCT ID: NCT05176782

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2022-03-15

Brief Summary

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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

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A (HTK cardioplegia)

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

Group Type ACTIVE_COMPARATOR

HTK cardioplegia

Intervention Type DRUG

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

Group B ( Cold Cardioplegia)

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 Type ACTIVE_COMPARATOR

Cold Cadioplegia

Intervention Type 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.

Interventions

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HTK cardioplegia

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

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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samar mohammed

Lecturer of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samar Soliman

Cairo, Nasr City, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Samar Soliman

Role: primary

01006236494 ext. 002

Other Identifiers

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FAMSU R 206/2021

Identifier Type: -

Identifier Source: org_study_id

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