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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Surgery Cardioplegia Heart Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Buckberg

Patients who will be administered Buckberg blood cardioplegia.

Group Type ACTIVE_COMPARATOR

Buckberg Cardi-Braun

Intervention Type DRUG

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

Custodiol

Patients who will be administered Custodiol crystalloid cardioplegia.

Group Type EXPERIMENTAL

Custodiol Htk Soln

Intervention Type DRUG

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

Interventions

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Custodiol Htk Soln

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

Intervention Type DRUG

Buckberg Cardi-Braun

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

Intervention Type DRUG

Other Intervention Names

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Custodiol HTK solution. ACT: K944866 Buckberg Cardi-Braun cardioplegia solution. ATC: B05X A16.

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No