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Clinical Trials in Spain / NCT06530641
Recruiting Phase 4

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

NCT06530641 · tracked via the Priya Life Science Spain tracker
Sponsor
Lourdes Montero Cruces
Phase
Phase 4
Started
2024-12-01
Last updated
2025-03-17

Condition(s) studied

Cardiac SurgeryCardioplegiaHeart Arrest

Investigational drug(s) / intervention(s)

Custodiol Htk SolnBuckberg Cardi-Braun

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

Buckberg Cardi-Braun: Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Comparison of the composite event — 90 days after the intervention
    Comparison of the composite event of death, perioperative AMI, low cardiac postoperative output with need for ionotropics, and AKIN-III acute kidney failure

Trial sites (1)

FacilityCityRegionStatus
Hospital Clínico San Carlos Madrid Madrid Recruiting

Other trials for the same condition

Observational Study of Platelet Dysfunction Assessed by Thromboelastography in Cardiovascular Surgery (DISPLATEG) Recruiting
Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06530641 on ClinicalTrials.gov ↗ ← All trials in Spain