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

Phase 4

• Conditions: Myocardial Injury
• Interventions: Drug: crystalloid cardioplegia solution; Drug: HTK solution

• Registration Number: NCT01548872
• Lead Sponsor: Baskent University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Status Verified: 2012-03
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-06
• Last Update Submitted: 2012-03-06
• Study First Posted: 2012-03-08
• Last Update Posted: 2012-03-08
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
crystalloid cardioplegia solution	crystalloid cardioplegia solution	After aortic cross clamp 30ml/kg will be administered
HTK solution	HTK solution	After aortic cross clamp 50ml/kg will be administered

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
hemodynamic and respiratory data	postoperative 48 hours	arterial pressures, heart rate,blood gas analysis

Trial Locations

Locations (1)

Baskent University, Faculty of Medicine; 🇹🇷 Ankara, Çankaya, Turkey