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

Phase 4

Recruiting

• Conditions: Cardiac Surgery; Cardioplegia; Heart Arrest
• Interventions: Drug: Buckberg Cardi-Braun; Drug: Custodiol Htk Soln

• Registration Number: NCT06530641
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-26
• Study First Posted: 2024-07-31
• Status Verified: 2024-12
• Study Start: 2024-12-01
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buckberg	Buckberg Cardi-Braun	Patients who will be administered Buckberg blood cardioplegia.
Custodiol	Custodiol Htk Soln	Patients who will be administered Custodiol crystalloid cardioplegia.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Differences in the incidence of elevation of Troponin	90 days after the intervention	Comparison of the elevation of Troponin I US at 12 and 24 hours after the procedure.
Differences in the 90-day mortality rate	90 days after the intervention	Comparison of 90-day postoperative mortality
Differences in the incidence of low cardiac postoperative output	90 days after the intervention	Comparison of low cardiac postoperative output event with need for ionotropic drugs in the first 24 hours.
Differences in the incidence of acute kidney failure event	90 days after the intervention	Comparison of AKIN-III acute kidney failure event
Differences in the incidence of acute myocardial infarction	90 days after the intervention	Comparison of perioperative AMI incidence
Differences in the incidence of major bleeding event	90 days after the intervention	Comparison of major bleeding event or life-threatening or disabling hemorrhage.
Differences in the incidence of the need of transfusion	90 days after the intervention	Comparison of the need for transfusion of blood products (absolute number) in the first 48 hours.
Differences in the incidence of prolonged mechanical ventilation	90 days after the intervention	Comparison of the need for prolonged mechanical ventilation for \>24h.
Differences in the incidence of neurological complications	90 days after the intervention	Comparison of type 1 and type 2 neurological complications.
Differences in the incidence of postoperative atrial fibrillation.	90 days after the intervention	Comparison of the incidence of postoperative atrial fibrillation.
Differences in the overall survival rate at 90 days.	90 days after the intervention	Comparison of overall survival at 90 days.

Trial Locations

Locations (1)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain