Cardiac SurgeryPhase 4NCT06530641
Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.
A Phase 4 study testing Custodiol Htk Soln and Buckberg Cardi-Braun in people with Cardiac Surgery and Cardioplegia, run by Lourdes Montero Cruces at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Cardioplegia, Heart Arrest
- What is being tested?
- Custodiol Htk Soln and Buckberg Cardi-Braun
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2024to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age.
- Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Lourdes Montero Cruces, 913303000, l.monterocr@gmail.com
About this study
Official 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.
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.
Read the 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.
- Conditions
- Cardiac Surgery, Cardioplegia, Heart Arrest
- Being tested
- Custodiol Htk Soln, Buckberg Cardi-Braun
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custodiol Htk SolnDrug
Also called Custodiol HTK solution. ACT: K944866
Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia.
Buckberg Cardi-BraunDrug
Also called Buckberg Cardi-Braun cardioplegia solution. ATC: B05X A16.
Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia.
| Study group | Role | What they receive |
|---|---|---|
| Buckberg | Active comparator | Patients who will be administered Buckberg blood cardioplegia. Receives: Drug: Buckberg Cardi-Braun |
| Custodiol | Experimental | Patients who will be administered Custodiol crystalloid cardioplegia. Receives: Drug: Custodiol Htk Soln |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days after the intervention
Secondary outcomes (11)
Differences in the incidence of elevation of Troponin
Comparison of the elevation of Troponin I US at 12 and 24 hours after the procedure.
Measured: 90 days after the intervention
Differences in the 90-day mortality rate
Comparison of 90-day postoperative mortality
Measured: 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.
Measured: 90 days after the intervention
Differences in the incidence of acute kidney failure event
Comparison of AKIN-III acute kidney failure event
Measured: 90 days after the intervention
Differences in the incidence of acute myocardial infarction
Comparison of perioperative AMI incidence
Measured: 90 days after the intervention
Differences in the incidence of major bleeding event
Comparison of major bleeding event or life-threatening or disabling hemorrhage.
Measured: 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.
Measured: 90 days after the intervention
Differences in the incidence of prolonged mechanical ventilation
Comparison of the need for prolonged mechanical ventilation for >24h.
Measured: 90 days after the intervention
Differences in the incidence of neurological complications
Comparison of type 1 and type 2 neurological complications.
Measured: 90 days after the intervention
Differences in the incidence of postoperative atrial fibrillation.
Comparison of the incidence of postoperative atrial fibrillation.
Measured: 90 days after the intervention
Differences in the overall survival rate at 90 days.
Comparison of overall survival at 90 days.
Measured: 90 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Dec 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lourdes Montero Cruces
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lourdes Montero Cruces, Hospital San Carlos, Madrid
- Investigators
- Lourdes Montero Cruces, Principal investigator, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530641
- Sponsor's protocol ID
- 24/238-EC_M
- Status last verified
- Dec 2024
- First submitted
- 26 Jul 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06530641
- Acronym / sponsor ID
- 24/238-EC_M
- Conditions
- Cardiac Surgery, Cardioplegia, Heart Arrest
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Lourdes Montero CrucesUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Buckberg | Active comparator | Drug: Buckberg Cardi-BraunPatients who will be administered Buckberg blood cardioplegia. |
| Custodiol | Experimental | Drug: Custodiol Htk SolnPatients who will be administered Custodiol crystalloid cardioplegia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age.
- Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.
Key exclusion criteria (8 listed)
- Pregnancy.
- Aortic arch procedures.
- Procedures in which hypothermia <28ºC is expected during the intervention.
- Minimally invasive procedures "Port Access".
- Active endocarditis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custodiol Htk SolnAlso: Custodiol HTK solution. ACT: K944866Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia. | Drug | Custodiol |
| Buckberg Cardi-BraunAlso: Buckberg Cardi-Braun cardioplegia solution. ATC: B05X A16.Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia. | Drug | Buckberg |
Primary outcome
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
11 secondary outcomes
Differences in the incidence of elevation of Troponin
Time frame: 90 days after the intervention
Differences in the 90-day mortality rate
Time frame: 90 days after the intervention
Differences in the incidence of low cardiac postoperative output
Time frame: 90 days after the intervention
Differences in the incidence of acute kidney failure event
Time frame: 90 days after the intervention
Differences in the incidence of acute myocardial infarction
Time frame: 90 days after the intervention
Differences in the incidence of major bleeding event
Time frame: 90 days after the intervention
Differences in the incidence of the need of transfusion
Time frame: 90 days after the intervention
Differences in the incidence of prolonged mechanical ventilation
Time frame: 90 days after the intervention
Differences in the incidence of neurological complications
Time frame: 90 days after the intervention
Differences in the incidence of postoperative atrial fibrillation.
Time frame: 90 days after the intervention
Differences in the overall survival rate at 90 days.
Time frame: 90 days after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lourdes Montero Cruces principal investigator
Hospital San Carlos, Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Custodiol Htk Soln and Buckberg Cardi-Braun in people with Cardiac Surgery and Cardioplegia, run by Lourdes Montero Cruces at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lourdes Montero Cruces (913303000, lourdes.montero@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the composite event (time frame: 90 days after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.