Status:
RECRUITING
Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.
Lead Sponsor:
Lourdes Montero Cruces
Conditions:
Cardiac Surgery
Cardioplegia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Phase IV clinical trial of a single-blind, prospective and longitudinal randomized intervention comparing patients undergoing major cardiac surgery with extracorporeal circulation who are administered...
Detailed Description
Myocardial protection by administering cardioplegia is a fundamental concept during cardiopulmonary bypass in patients undergoing cardiac surgery. It is a multifactorial strategy, in which cardioplegi...
Eligibility Criteria
Inclusion
- Patients over 18 years of age.
- Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.
Exclusion
- Pregnancy.
- Aortic arch procedures.
- Procedures in which hypothermia \<28ºC is expected during the intervention.
- Minimally invasive procedures "Port Access".
- Active endocarditis.
- Emerging procedures.
- Isolated aortic valve replacements.
- Decision of the main surgeon not to participate in the study due to other clinical criteria.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06530641
Start Date
December 1 2024
End Date
December 1 2026
Last Update
March 17 2025
Active Locations (1)
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1
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040