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

NCT06530641 | Recruiting Phase 4 DMC

• 1 other identifier: 24/238-EC_M
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Cardioplegia; Heart Arrest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Differences in the incidence of elevation of Troponin

  90 days after the intervention

• Differences in the 90-day mortality rate

  90 days after the intervention

• Differences in the incidence of low cardiac postoperative output

  90 days after the intervention

• Differences in the incidence of acute kidney failure event

  90 days after the intervention

• Differences in the incidence of acute myocardial infarction

  90 days after the intervention

Study Arms (2)

Buckberg

ACTIVE COMPARATOR

Patients who will be administered Buckberg blood cardioplegia.

Drug: Buckberg Cardi-Braun

Custodiol

EXPERIMENTAL

Patients who will be administered Custodiol crystalloid cardioplegia.

Drug: Custodiol Htk Soln

Interventions

Custodiol Htk Soln DRUG

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

Also known as: Custodiol HTK solution. ACT: K944866

Custodiol

Buckberg Cardi-Braun DRUG

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

Also known as: Buckberg Cardi-Braun cardioplegia solution. ATC: B05X A16.

Buckberg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age.
• Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.

You may not qualify if:

• Pregnancy.
• Aortic arch procedures.
• Procedures in which hypothermia \<28ºC is expected during the intervention.
• Minimally invasive procedures "Port Access".
• Active endocarditis.
• Emerging procedures.
• Isolated aortic valve replacements.
• Decision of the main surgeon not to participate in the study due to other clinical criteria.

Sponsors & Collaborators

• Lourdes Montero Cruces: lead

Study Sites (1)

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Lourdes Montero Cruces

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lourdes Montero Cruces

CONTACT

913303000; lourdes.montero@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)