Comparing two types of cardioplegia in major heart surgery
Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery with Extracorporeal Circulation. CARDIO-HEART Clinical Trial.
This study tests whether a type of heart surgery solution called Custodiol works just as well as another solution, Buckberg, in protecting the heart during major surgeries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital San Carlos, Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT06530641 on ClinicalTrials.gov |
What this trial studies
This phase IV clinical trial is a single-blind, prospective, and longitudinal randomized intervention that compares the effects of Custodiol crystalloid cardioplegia and Buckberg blood cardioplegia in patients undergoing major cardiac surgery with extracorporeal circulation. The study aims to evaluate the non-inferiority of Custodiol cardioplegia, particularly in complex surgeries requiring longer aortic clamping times. By addressing the lack of standardized consensus on cardioplegia use, this trial seeks to provide clearer guidance on myocardial protection strategies during cardiac surgery. The trial will involve patients over 18 years of age with specific cardiac pathologies indicated for surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with cardiac conditions requiring major surgery involving extracorporeal circulation.
Not a fit: Patients with conditions such as pregnancy, aortic arch procedures, or those undergoing minimally invasive surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved myocardial protection strategies during major cardiac surgeries, enhancing patient outcomes.
How similar studies have performed: While there is limited literature on this specific comparison, previous studies have shown varying outcomes with different cardioplegia methods, indicating the need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age. * Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping. Exclusion Criteria: 1. Pregnancy. 2. Aortic arch procedures. 3. Procedures in which hypothermia \<28ºC is expected during the intervention. 4. Minimally invasive procedures "Port Access". 5. Active endocarditis. 6. Emerging procedures. 7. Isolated aortic valve replacements. 8. Decision of the main surgeon not to participate in the study due to other clinical criteria.
Where this trial is running
Madrid, Madrid
- Hospital Clínico San Carlos — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Lourdes Montero Cruces — Hospital San Carlos, Madrid
- Study coordinator: Lourdes Montero Cruces
- Email: lourdes.montero@salud.madrid.org
- Phone: 913303000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.