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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01548872
First Posted: March 8, 2012
Last Update Posted: March 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Selim Kuslu, Baskent University
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548872


Contacts
Contact: Selim Kuşlu +90 312 212 68 68 ext 1172 selimkuslu@gmail.com
Contact: Pınar Zeyneloğlu + 90 312 212 68 68 ext 1800 pinar.zeyneloglu@gmail.com

Locations
Turkey
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
ClinicalTrials.gov Identifier: NCT01548872     History of Changes
Other Study ID Numbers: KA/11-152
First Submitted: March 6, 2012
First Posted: March 8, 2012
Last Update Posted: March 8, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Mannitol
Procaine
Cardioplegic Solutions
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents