Comparison of the Effects of Crystalloid Cardioplegia and HTK Solution for Postoperative Troponin-I and CK-MB Levels After Pediatric Cardiac Surgery
This study is currently recruiting participants.
Verified March 2012 by Baskent University
Sponsor:
Baskent University
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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | March 6, 2012 | ||||||||
| Last Updated Date | March 6, 2012 | ||||||||
| Start Date ICMJE | December 2011 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
hemodynamic and respiratory data [ Time Frame: postoperative 48 hours ] [ Designated as safety issue: Yes ] arterial pressures, heart rate,blood gas analysis |
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparison of the Effects of Crystalloid Cardioplegia and HTK Solution for Postoperative Troponin-I and CK-MB Levels After Pediatric Cardiac Surgery | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
||||||||
| Condition ICMJE | Myocardial Injury | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 1 Month to 6 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Turkey | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01548872 | ||||||||
| Other Study ID Numbers ICMJE | KA/11-152 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Selim Kuslu, Baskent University | ||||||||
| Study Sponsor ICMJE | Baskent University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Baskent University | ||||||||
| Verification Date | March 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||