Clinical trial NCT06530641: Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cardiac Surgery
Cardioplegia
Heart Arrest
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Once the patient is included in the study, they will be assigned an identification number and a treatment group.

* Group 1: Patients who will be administered Buckberg blood cardioplegia.
* Group 2: Patients who will be administered Custodiol crystalloid cardioplegia. A 1:1 randomization will be carried out by blocks and stratified by weight of the intervention according to the EuroSCORE II:

  * Weight 1: Any major cardiac procedure (40% of the sample).
  * Weight 2: Two major cardiac procedures (40% of the sample).
  * Weight 3: Three or more major cardiac procedures (20% of the sample).
Primary purpose: OTHER

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.

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.

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.

Primary outcomes:
measure: Comparison of the composite event
timeFrame: 90 days after the intervention
Secondary outcomes:
measure: Differences in the incidence of elevation of Troponin
timeFrame: 90 days after the intervention
measure: Differences in the 90-day mortality rate
timeFrame: 90 days after the intervention
measure: Differences in the incidence of low cardiac postoperative output
timeFrame: 90 days after the intervention
measure: Differences in the incidence of acute kidney failure event
timeFrame: 90 days after the intervention
measure: Differences in the incidence of acute myocardial infarction
timeFrame: 90 days after the intervention
measure: Differences in the incidence of major bleeding event
timeFrame: 90 days after the intervention
measure: Differences in the incidence of the need of transfusion
timeFrame: 90 days after the intervention
measure: Differences in the incidence of prolonged mechanical ventilation
timeFrame: 90 days after the intervention
measure: Differences in the incidence of neurological complications
timeFrame: 90 days after the intervention
measure: Differences in the incidence of postoperative atrial fibrillation.
timeFrame: 90 days after the intervention
measure: Differences in the overall survival rate at 90 days.
timeFrame: 90 days after the intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: Hospital San Carlos, Madrid
name: Lourdes Montero Cruces
role: PRINCIPAL_INVESTIGATOR
References: