AnesthesiaEarly Phase 1NCT05176782
Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair
A Early Phase 1 study testing HTK cardioplegia and Cold Cadioplegia in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- HTK cardioplegia and Cold Cadioplegia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2021to 15 Mar 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients with tetralogy of Fallot spectrum.
- Sex (males and females)
- Age 6 months- 5 years.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Samar Soliman
Cairo, Nasr City, 11511
Samar Soliman, 01006236494 ext. 002, dr_sm.md@hotmail.com
About this study
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
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
- Being tested
- HTK cardioplegia, Cold Cadioplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTK cardioplegiaDrug
will receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula.
Cold CadioplegiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (HTK cardioplegia) | Active comparator | will receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula. Receives: 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. Receives: Drug: Cold Cadioplegia |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Vasoactive-Inotropic Score
Calculate the doses of vasoactive drugs used
Measured: From time of separation of cardioplumonary bypass till 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start15 Dec 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samar mohammed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176782
- Sponsor's protocol ID
- FAMSU R 206/2021
- Status last verified
- Jan 2022
- First submitted
- 15 Dec 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05176782
- Acronym / sponsor ID
- FAMSU R 206/2021
- Conditions
- Anesthesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (HTK cardioplegia) | Active comparator | Drug: HTK cardioplegiawill receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula. |
| Group B ( Cold Cardioplegia) | Active comparator | Drug: Cold Cadioplegiawill 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. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients with tetralogy of Fallot spectrum.
- Sex (males and females)
- Age 6 months- 5 years.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTK cardioplegiawill receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula. | Drug | Group A (HTK cardioplegia) |
| Cold Cadioplegiaas 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. | Drug | Group B ( Cold Cardioplegia) |
Primary outcome
• Vasoactive-Inotropic Score
Time frame: From time of separation of cardioplumonary bypass till 24 hours post operative
Calculate the doses of vasoactive drugs used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HTK cardioplegia and Cold Cadioplegia in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Vasoactive-Inotropic Score (time frame: From time of separation of cardioplumonary bypass till 24 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.