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

Sponsor

Baskent University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01548872

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Injury	Drug: HTK solution Drug: crystalloid cardioplegia solution	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Study Start Date :

Dec 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: crystalloid cardioplegia solution After aortic cross clamp 30ml/kg will be administered	Drug: crystalloid cardioplegia solution 30 ml/kg bolus in two minutes
Active Comparator: HTK solution After aortic cross clamp 50ml/kg will be administered	Drug: HTK solution 50 ml/kg bolus in 2 minutes

Arm

Intervention/Treatment

Active Comparator: crystalloid cardioplegia solution

After aortic cross clamp 30ml/kg will be administered

Drug: crystalloid cardioplegia solution

30 ml/kg bolus in two minutes

Active Comparator: HTK solution

After aortic cross clamp 50ml/kg will be administered

Drug: HTK solution

50 ml/kg bolus in 2 minutes

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

hemodynamic and respiratory data [postoperative 48 hours]
arterial pressures, heart rate,blood gas analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 6 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baskent University, Faculty of Medicine	Ankara	Çankaya	Turkey	06490

Sponsors and Collaborators

Baskent University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Selim Kuslu, Anesthesiology Resident, Baskent University

ClinicalTrials.gov Identifier:

NCT01548872

Other Study ID Numbers:

KA/11-152

First Posted:

Mar 8, 2012

Last Update Posted:

Mar 8, 2012

Last Verified:

Mar 1, 2012

Keywords provided by Selim Kuslu, Anesthesiology Resident, Baskent University

HTk solution

Cardioplegia

myocardial protection

pediatric cardiac surgery

Additional relevant MeSH terms:

Cardioplegic Solutions

Pharmaceutical Solutions

Study Results

No Results Posted as of Mar 8, 2012