Back to resultsComparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair
Primary Purpose
Anesthesia
Status
Recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
HTK cardioplegia
Cold Cadioplegia
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia
Eligibility Criteria
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)
Sites / Locations
- Samar SolimanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A (HTK cardioplegia)
Group B ( Cold Cardioplegia)
Arm Description
will receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula.
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.
Outcomes
Primary Outcome Measures
• Vasoactive-Inotropic Score
Calculate the doses of vasoactive drugs used
Secondary Outcome Measures
Full Information
NCT ID
NCT05176782
First Posted
December 15, 2021
Last Updated
January 3, 2022
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05176782
Brief Title
Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A (HTK cardioplegia)
Arm Type
Active Comparator
Arm Description
will receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula.
Arm Title
Group B ( Cold Cardioplegia)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
HTK cardioplegia
Intervention Description
will receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula.
Intervention Type
Drug
Intervention Name(s)
Cold Cadioplegia
Intervention Description
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.
Primary Outcome Measure Information:
Title
• Vasoactive-Inotropic Score
Description
Calculate the doses of vasoactive drugs used
Time Frame
From time of separation of cardioplumonary bypass till 24 hours post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Samar Soliman
City
Cairo
State/Province
Nasr City
ZIP/Postal Code
11511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samar Soliman
Phone
01006236494
Ext
002
Email
dr_sm.md@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair
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