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Comparative study on the effect of Del Nido cardioplegia (with or without blood) on myocardial protection in congenital and adult cardiac surgery

INveStigation of myocardial Protection of orIginal vs bloodless del nido cardioplegia in congenital and adult caRdiac surgEry (INSPIRE)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010454
Enrollment
700
Registered
2025-04-30
Start date
2025-05-19
Completion date
Unknown
Last updated
2025-05-07

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

Conditions

None listed

Interventions

Drug : The perfusionist participating in the surgery mixes the cardioplegia solution according to the composition of the assigned group and administers it in the same manner for both groups. The compo

Sponsors

BUCHEON SEJONG HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1-1) Adult inclusion criteria ? Adults aged 19 years or older ? Patients undergoing cardiac surgery using cardiopulmonary bypass ? Patients undergoing surgery under cardiac arrest using cardioplegia solution ? Patients who voluntarily agree to participate in this study and have provided informed consent 2-1) Pediatric inclusion criteria ? Patients under 7 years of age diagnosed with congenital heart defects who are undergoing open-heart surgery using cardiopulmonary bypass at our institution, with consent obtained from their legal guardian ? Target congenital heart defects: Atrial septal defect (ASD), Ventricular septal defect (VSD), Double outlet right ventricle (DORV), Tetralogy of Fallot (TOF), Partial anomalous pulmonary venous return (PAPVR), Total anomalous pulmonary venous return (TAPVR) ? Patients undergoing surgery under cardiac arrest using cardioplegia solution

Exclusion criteria

Exclusion criteria: 1-2) Adult exclusion criteria ? Aortic surgery ? Patients undergoing reoperation with a history of previous open-heart surgery ? Cases where surgery is performed under ventricular fibrillation or with the heart beating without using an aortic cross-clamp ? Emergency surgeries ? Patients requiring preoperative support with inotropes, mechanical ventilation, or mechanical assist devices ? Patients with active infections or infectious diseases classified as Category 1, 2, or 3 under Article 2, Paragraph 1 of the Infectious Disease Control and Prevention Act 2-2) Pediatric exclusion criteria ? Patients undergoing reoperation with a history of previous open-heart surgery ? Patients requiring preoperative intensive care unit treatment or emergency surgery ? Patients diagnosed with complex congenital heart defects involving multiple anomalies or single ventricle physiology ? Patients with congenital anomalies affecting organs other than the heart ? Patients clinically suspected or confirmed to have complex genetic syndromes ? Patients clinically suspected or confirmed to have active infections or infectious diseases classified as Category 1, 2, or 3 under Article 2, Paragraph 1 of the Infectious Disease Control and Prevention Act

Design outcomes

Primary

MeasureTime frame
Postoperative Troponin-T level

Secondary

MeasureTime frame
Lactate level;Vasoactive Inotropic score;Low cardiac output syndrome requiring mechanical circulatory support;In hospital mortality;MACCE(myocardial infarction, stroke, bleeding, acute kidney injury, infection)

Countries

Korea, Republic of

Contacts

Public ContactHeemoon Lee

BUCHEON SEJONG HOSPITAL

rhythmists@gmail.com+82-32-340-1425

Outcome results

None listed

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