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NCT Number: NCT06530641

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location status: Recruiting

Location contact

Lourdes Montero Cruces

CONTACT

[email protected]

913303000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Custodiol Htk Soln

Drug

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

Other names: Custodiol HTK solution. ACT: K944866

Buckberg Cardi-Braun

Drug

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

Other names: Buckberg Cardi-Braun cardioplegia solution. ATC: B05X A16.

Primary outcomes

  1. Comparison of the composite event

    Time frame: 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 outcomes

  1. Differences in the incidence of elevation of Troponin

    Time frame: 90 days after the intervention

    Comparison of the elevation of Troponin I US at 12 and 24 hours after the procedure.

  2. Differences in the 90-day mortality rate

    Time frame: 90 days after the intervention

    Comparison of 90-day postoperative mortality

  3. Differences in the incidence of low cardiac postoperative output

    Time frame: 90 days after the intervention

    Comparison of low cardiac postoperative output event with need for ionotropic drugs in the first 24 hours.

  4. Differences in the incidence of acute kidney failure event

    Time frame: 90 days after the intervention

    Comparison of AKIN-III acute kidney failure event

  5. Differences in the incidence of acute myocardial infarction

    Time frame: 90 days after the intervention

    Comparison of perioperative AMI incidence

  6. Differences in the incidence of major bleeding event

    Time frame: 90 days after the intervention

    Comparison of major bleeding event or life-threatening or disabling hemorrhage.

  7. Differences in the incidence of the need of transfusion

    Time frame: 90 days after the intervention

    Comparison of the need for transfusion of blood products (absolute number) in the first 48 hours.

  8. Differences in the incidence of prolonged mechanical ventilation

    Time frame: 90 days after the intervention

    Comparison of the need for prolonged mechanical ventilation for >24h.

  9. Differences in the incidence of neurological complications

    Time frame: 90 days after the intervention

    Comparison of type 1 and type 2 neurological complications.

  10. Differences in the incidence of postoperative atrial fibrillation.

    Time frame: 90 days after the intervention

    Comparison of the incidence of postoperative atrial fibrillation.

  11. Differences in the overall survival rate at 90 days.

    Time frame: 90 days after the intervention

    Comparison of overall survival at 90 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Lourdes Montero Cruces

CONTACT

[email protected]

913303000

Sponsors and collaborators

Lead sponsor

Lourdes Montero Cruces

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2024
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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