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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016042627617N1

Enrollment

Registered

2016-06-12

Start date

2016-02-20

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetralogy of Fallot, Congenital Heart Diseases. Ventricular septal defect with pulmonary stenosis or atresia, dextroposition of aorta and hypertrophy of right ventricle.

Interventions

Intervention 1: Del Nido cardioplegia: a cardioplegia solution containing 1:4 ratio of patients oxygenated blood to crystalloid part which is administered in single dose and antegrade manner. Interven

Treatment - Drugs

Del Nido cardioplegia: a cardioplegia solution containing 1:4 ratio of patients oxygenated blood to crystalloid part which is administered in single dose and antegrade manner.

modified St. Thomas' solution which consist of a 4 parts of patients oxygenated blood and one part of crystaloid solution administered every 20 minutes in anegrade manner.

Eligibility

Sex/Gender

All

Age

4 Months to 5 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Maziar Gholampour Dehaki

Rajaei Cardiovascular and Medical Center

drgholampour@yahoo.com+98 21 2392 2169

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026