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

Baskent University

Status and phase: Unknown; Phase 4

Conditions: Myocardial Injury

Treatments: Drug: crystalloid cardioplegia solution; Drug: HTK solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01548872

KA/11-152

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 month to 6 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

crystalloid cardioplegia solution

Active Comparator group

Description:

After aortic cross clamp 30ml/kg will be administered

Treatment:

Drug: crystalloid cardioplegia solution

HTK solution

Active Comparator group

Description:

After aortic cross clamp 50ml/kg will be administered

Treatment:

Drug: HTK solution