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

Myocardial Injury Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01548872
• Other study ID #: KA/11-152
• Status: Recruiting
• Phase: Phase 4
• First received: March 6, 2012
• Last updated: March 6, 2012
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: Baskent University
• Contact: Selim Kuslu
• Phone: +90 312 212 68 68
• Email: selimkuslu[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myocardial Injury

Intervention

Drug:
• HTK solution
50 ml/kg bolus in 2 minutes
• crystalloid cardioplegia solution
30 ml/kg bolus in two minutes

Locations

Country	Name	City	State
Turkey	Baskent University, Faculty of Medicine	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardial protective effect of HTK solution	to detect %33 difference in Troponin-I levels 4 hours postoperatively	postoperative 48 hours	Yes
Secondary	hemodynamic and respiratory data	arterial pressures, heart rate,blood gas analysis	postoperative 48 hours	Yes