RecruitingPhase 4NCT06530641

Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac 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.


Sponsor

Lourdes Montero Cruces

Enrollment

600 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

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 Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Patients over 18 years of age.
  • Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.

Exclusion Criteria8

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCustodiol Htk Soln

Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia.

DRUGBuckberg Cardi-Braun

Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia.


Locations(1)

Hospital Clínico San Carlos

Madrid, Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06530641


Related Trials