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

NCT ID: NCT01548872

Last Updated: 2012-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Myocardial Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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crystalloid cardioplegia solution

After aortic cross clamp 30ml/kg will be administered

Group Type ACTIVE_COMPARATOR

crystalloid cardioplegia solution

Intervention Type DRUG

30 ml/kg bolus in two minutes

HTK solution

After aortic cross clamp 50ml/kg will be administered

Group Type ACTIVE_COMPARATOR

HTK solution

Intervention Type DRUG

50 ml/kg bolus in 2 minutes

Interventions

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HTK solution

50 ml/kg bolus in 2 minutes

Intervention Type DRUG

crystalloid cardioplegia solution

30 ml/kg bolus in two minutes

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Selim Kuslu

Anesthesiology Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baskent University, Faculty of Medicine

Ankara, Çankaya, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Selim Kuşlu

Role: CONTACT

+90 312 212 68 68 ext. 1172

Pınar Zeyneloğlu

Role: CONTACT

+ 90 312 212 68 68 ext. 1800

Other Identifiers

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KA/11-152

Identifier Type: -

Identifier Source: org_study_id

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