Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Custodiol Htk Soln, Buckberg Cardi-Braun.
- Who it may be relevant to
- Registry conditions: Cardiac Surgery, Cardioplegia, Heart Arrest. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Drug Custodiol Htk Soln
Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia. - Drug Buckberg Cardi-Braun
Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia.
Primary outcome measures
- Comparison of the composite event [Time frame: 90 days after the intervention]
Secondary outcome measures (11)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Spain · 1 center
- Hospital Clínico San Carlos — Madrid
Identifiers
NCT: NCT06530641 · 24/238-EC_M