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NCT06530641 | RECRUITING | Cardiac Surgery

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

Lourdes Montero Cruces

Information provided by (Responsible Party):

Lourdes Montero Cruces

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 Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia.

Condition or disease

Cardiac Surgery

Cardioplegia

Heart Arrest

Intervention/treatment

Custodiol Htk Soln

Buckberg Cardi-Braun

Phase

PHASE4

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 cardioplegia is the most important. To date, there is no standardized consensus on the use of cardioplegia in different cardiac surgery procedures, and the best strategy continues to be debated given the wide range available. The choice of the type of cardioplegia should be made on an individual basis, taking into account the surgical procedure and clinical context. The need for a single dose of cardioplegia could favor the use of Custodiol crystaloid cardioplegia in complex cardiac surgeries that require longer extracorporeal circulation time. Both cardioplegia are safe and effective and widely used globally; however, the information provided in the literature is limited, with most of the information coming from retrospective studies.The objective of the present study is to demonstrate the non-inferiority of Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia in patients undergoing major cardiac surgery with extracorporeal circulation with prolonged aortic clamping times.

Study Type : INTERVENTIONAL
Estimated Enrollment : 600 participants
Masking : SINGLE
Primary Purpose : OTHER
Official Title : Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery with Extracorporeal Circulation. CARDIO-HEART Clinical Trial.
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2026-11
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.

Location Details

NCT06530641

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Locations

RECRUITING

Spain, Madrid

San Carlos Clinical Hospital

Madrid, Madrid, Spain, 28040