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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Selim Kuslu, Baskent University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Selim Kuslu, Baskent University Identifier:
First received: March 6, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
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 Intervention Phase
Myocardial Injury Drug: HTK solution Drug: crystalloid cardioplegia solution Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Selim Kuslu, Baskent University:

Primary Outcome Measures:
  • myocardial protective effect of HTK solution [ Time Frame: postoperative 48 hours ]
    to detect %33 difference in Troponin-I levels 4 hours postoperatively

Secondary Outcome Measures:
  • hemodynamic and respiratory data [ Time Frame: postoperative 48 hours ]
    arterial pressures, heart rate,blood gas analysis

Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   1 Month to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01548872

Contact: Selim Kuşlu +90 312 212 68 68 ext 1172
Contact: Pınar Zeyneloğlu + 90 312 212 68 68 ext 1800

Baskent University, Faculty of Medicine Recruiting
Ankara, Çankaya, Turkey, 06490
Principal Investigator: Selim Kuşlu         
Sponsors and Collaborators
Baskent University
  More Information

Responsible Party: Selim Kuslu, Anesthesiology Resident, Baskent University Identifier: NCT01548872     History of Changes
Other Study ID Numbers: KA/11-152
Study First Received: March 6, 2012
Last Updated: March 6, 2012

Keywords provided by Selim Kuslu, Baskent University:
HTk solution
myocardial protection
pediatric cardiac surgery

Additional relevant MeSH terms:
Pharmaceutical Solutions
Cardioplegic Solutions
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs
Anesthetics, Local
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents processed this record on August 17, 2017