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 because the information has not been verified recently.
Verified March 2012 by Baskent University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Selim Kuslu, Baskent University
ClinicalTrials.gov Identifier:
NCT01548872
First received: March 6, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted

March 6, 2012
March 6, 2012
December 2011
December 2012   (final data collection date for primary outcome measure)
myocardial protective effect of HTK solution [ Time Frame: postoperative 48 hours ] [ Designated as safety issue: Yes ]
to detect %33 difference in Troponin-I levels 4 hours postoperatively
Same as current
No Changes Posted
hemodynamic and respiratory data [ Time Frame: postoperative 48 hours ] [ Designated as safety issue: Yes ]
arterial pressures, heart rate,blood gas analysis
Same as current
Not Provided
Not Provided
 
Comparison of the Effects of Crystalloid Cardioplegia and HTK Solution for Postoperative Troponin-I and CK-MB Levels After Pediatric Cardiac Surgery
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Myocardial Injury
  • Drug: HTK solution
    50 ml/kg bolus in 2 minutes
  • Drug: crystalloid cardioplegia solution
    30 ml/kg bolus in two minutes
  • Active Comparator: crystalloid cardioplegia solution
    After aortic cross clamp 30ml/kg will be administered
    Intervention: Drug: crystalloid cardioplegia solution
  • Active Comparator: HTK solution
    After aortic cross clamp 50ml/kg will be administered
    Intervention: Drug: HTK solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
1 Month to 6 Years
No
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
Turkey
 
NCT01548872
KA/11-152
Yes
Selim Kuslu, Baskent University
Baskent University
Not Provided
Not Provided
Baskent University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP