Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.
Launched by LOURDES MONTERO CRUCES · Jul 26, 2024
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of different types of cardioplegia, which is a solution used to protect the heart during major cardiac surgery when the heart is temporarily stopped. The trial is comparing two specific methods: one using a special crystalloid solution called Custodiol and the other using blood known as Buckberg. Researchers want to see which method has a better impact on patients during and after their surgery.
To be eligible for this study, participants should be adults over 18 years old who are scheduled for major heart surgery that requires stopping the heart and using a heart-lung machine. However, some people may not qualify, including those who are pregnant or have certain heart conditions. If you join the study, you will be randomly assigned to receive one of the two cardioplegia methods. The trial is currently seeking participants, and it aims to gather valuable information that could help improve heart surgery care in the future.
Gender
ALL
Eligibility 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.
About Lourdes Montero Cruces
Lourdes Montero Cruces is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With expertise in managing and overseeing clinical trials across various therapeutic areas, the organization prioritizes adherence to regulatory standards and ethical practices. Lourdes Montero Cruces collaborates with healthcare professionals and research institutions to facilitate innovative studies that aim to develop new therapies and enhance existing treatments. Their focus on rigorous data collection and analysis ensures the integrity of research findings, ultimately contributing to the advancement of healthcare knowledge and patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
Patients applied
Trial Officials
Lourdes Montero Cruces
Principal Investigator
Hospital San Carlos, Madrid
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported