Comparison of the Effects of Crystalloid Cardioplegia and HTK Solution for Postoperative Troponin-I and CK-MB Levels After Pediatric Cardiac Surgery

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01548872

Enrollment

Registered

2012-03-08

Start date

2011-12-31

Completion date

2012-12-31

Last updated

2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Injury

Keywords

HTk solution, Cardioplegia, myocardial protection, pediatric cardiac surgery

Brief 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.

Interventions

DRUGHTK solution

50 ml/kg bolus in 2 minutes

DRUGcrystalloid cardioplegia solution

30 ml/kg bolus in two minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Months to 6 Years

Healthy volunteers

Inclusion criteria

* Patients scheduled for elective pediatric cardiac surgery * Patients written informed consent for study participation

Exclusion criteria

* redo surgery * allergy to study drugs * unstable blood pressure before cardiac surgery

Design outcomes

Primary

Measure	Time frame	Description
myocardial protective effect of HTK solution	postoperative 48 hours	to detect %33 difference in Troponin-I levels 4 hours postoperatively

Secondary

Measure	Time frame	Description
hemodynamic and respiratory data	postoperative 48 hours	arterial pressures, heart rate,blood gas analysis

Countries

Turkey (Türkiye)

Contacts

Primary ContactSelim Kuşlu

selimkuslu@gmail.com+90 312 212 68 68

Backup ContactPınar Zeyneloğlu

pinar.zeyneloglu@gmail.com+ 90 312 212 68 68

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026