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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

This study is currently recruiting participants.
Verified March 2012 by Baskent University
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Baskent University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • hemodynamic and respiratory data [ Time Frame: postoperative 48 hours ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   1 Month to 6 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on May 23, 2013