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

Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery with Extracorporeal Circulation. CARDIO-HEART Clinical Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Arrest; Cardiac Surgery; Cardioplegia
• Intervention / Treatment: Drug: Buckberg Cardi-Braun; Drug: Custodiol Htk Soln

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
• Enrollment (Estimated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lourdes Montero Cruces; Phone Number: 913303000; Email: lourdes.montero@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
    • Contact: Lourdes Montero Cruces; Phone Number: 913303000; Email: l.monterocr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Buckberg; Patients who will be administered Buckberg blood cardioplegia.	Drug: Buckberg Cardi-Braun; Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia.; Other Names: Buckberg Cardi-Braun cardioplegia solution. ATC: B05X A16.
Experimental: Custodiol; Patients who will be administered Custodiol crystalloid cardioplegia.	Drug: Custodiol Htk Soln; Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia.; Other Names: Custodiol HTK solution. ACT: K944866

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lourdes Montero Cruces
• Investigators: Principal Investigator: Lourdes Montero Cruces, Hospital San Carlos, Madrid

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Pharmaceutical Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: 24/238-EC_M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No