Myocardial InjuryPhase 4NCT01548872
Comparison of the Effects of Crystalloid Cardioplegia and HTK Solution for Postoperative Troponin-I and CK-MB Levels After Pediatric Cardiac Surgery
A Phase 4 study testing HTK solution and crystalloid cardioplegia solution in people with Myocardial Injury, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare two different cardioplegia solutions effect on postoperative Troponin-I and CK-MB levels after pediatric cardiac surgery. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Myocardial Injury
- What is being tested?
- HTK solution and crystalloid cardioplegia solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2011to Dec 2012
- Phase
- Phase 4
- 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 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients scheduled for elective pediatric cardiac surgery
- Patients written informed consent for study participation
Who cannot join
- redo surgery
- allergy to study drugs
- unstable blood pressure before cardiac surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University, Faculty of Medicine
Ankara, Çankaya, 06490
Selim Kuşlu
About this study
The purpose of this study is to compare two different cardioplegia solutions effect on postoperative Troponin-I and CK-MB levels after pediatric cardiac surgery.
- Conditions
- Myocardial Injury
- Being tested
- HTK solution, crystalloid cardioplegia solution
- Keywords
- HTk solution, Cardioplegia, myocardial protection, pediatric cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTK solutionDrug
50 ml/kg bolus in 2 minutes
crystalloid cardioplegia solutionDrug
30 ml/kg bolus in two minutes
| Study group | Role | What they receive |
|---|---|---|
| crystalloid cardioplegia solution | Active comparator | After aortic cross clamp 30ml/kg will be administered Receives: Drug: crystalloid cardioplegia solution |
| HTK solution | Active comparator | After aortic cross clamp 50ml/kg will be administered Receives: Drug: HTK solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial protective effect of HTK solution
to detect %33 difference in Troponin-I levels 4 hours postoperatively
Measured: postoperative 48 hours
Secondary outcomes (1)
hemodynamic and respiratory data
arterial pressures, heart rate,blood gas analysis
Measured: postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- 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
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selim Kuslu, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548872
- Sponsor's protocol ID
- KA/11-152
- Status last verified
- Mar 2012
- First submitted
- 6 Mar 2012
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Crystalloid Cardioplegia and HTK Solution for Postoperative Troponin-I and CK-MB Levels After Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01548872
- Acronym / sponsor ID
- KA/11-152
- Conditions
- Myocardial Injury
- Keywords
- HTk solution, Cardioplegia, myocardial protection, pediatric cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 8 Mar 2012 (estimated)
- 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.
The purpose of this study is to compare two different cardioplegia solutions effect on postoperative Troponin-I and CK-MB levels after pediatric cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| crystalloid cardioplegia solution | Active comparator | Drug: crystalloid cardioplegia solutionAfter aortic cross clamp 30ml/kg will be administered |
| HTK solution | Active comparator | Drug: HTK solutionAfter aortic cross clamp 50ml/kg will be administered |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients scheduled for elective pediatric cardiac surgery
- Patients written informed consent for study participation
Key exclusion criteria (3 listed)
- redo surgery
- allergy to study drugs
- unstable blood pressure before cardiac surgery
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 solution50 ml/kg bolus in 2 minutes | Drug | HTK solution |
| crystalloid cardioplegia solution30 ml/kg bolus in two minutes | Drug | crystalloid cardioplegia solution |
Primary outcome
myocardial protective effect of HTK solution
Time frame: postoperative 48 hours
to detect %33 difference in Troponin-I levels 4 hours postoperatively
1 secondary outcome
hemodynamic and respiratory data
Time frame: postoperative 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
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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 Phase 4 study testing HTK solution and crystalloid cardioplegia solution in people with Myocardial Injury, run by Baskent University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 8 Mar 2012. 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 Turkey (Türkiye). 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Selim Kuşlu (+90 312 212 68 68 ext. 1172, selimkuslu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial protective effect of HTK solution (time frame: postoperative 48 hours). 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 8 Mar 2012.