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Inflammatory response and cardiac muscle damage markers in pediatric cardiac surgery: effect of two cardioplegia solutions Del Nido” and blood cardioplegia”

Phase 2
Conditions
Tetralogy of Fallot, Congenital Heart Diseases.
Ventricular septal defect with pulmonary stenosis or atresia, dextroposition of aorta and hypertrophy of right ventricle.
Registration Number
IRCT2016042627617N1
Lead Sponsor
Vice chancellor for research, ?Administrative building, Rajaei cardiovascular and medical center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
30
Inclusion Criteria

informed consent of guardians; weight below or equal to 15 kg; candidate for cardiopulmonary bypass surgery; Congenital tetralogy of Fallot; Pump time between 1 to 3 hours; operation time between 4 and 5 hours

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cardiac troponin I (cTnI). Timepoint: before operation, after declamp and 24 hours post-operarion. Method of measurement: ELISA method.;Il-6. Timepoint: Before surgery, after declamp and 24 hours post ICU entrance. Method of measurement: ELISA method on plasma.;IL-8. Timepoint: Before surgery, after declamp and 24 hours post ICU entrance. Method of measurement: ELISA method on plasma.;IL-10. Timepoint: before operation, after declamp and 24 hours post-operarion. Method of measurement: ELISA method on plasma.;TNFa. Timepoint: before operation, after declamp and 24 hours post-operarion. Method of measurement: ELISA method on plasma.;Heart rate. Timepoint: every 3 hours from operation start until 24 hours post-operation. Method of measurement: Vital sign monitoring system.;Blood pressure. Timepoint: every 3 hours from operation start until 24 hours post-operation. Method of measurement: Vital sign monitoring system.
Secondary Outcome Measures
NameTimeMethod
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