Hospital Clínico San Carlos
Madrid, 28040, Spain
Location status: Recruiting
NCT Number: NCT06530641
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Madrid, 28040, Spain
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia.
Other names: Custodiol HTK solution. ACT: K944866
Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia.
Other names: Buckberg Cardi-Braun cardioplegia solution. ATC: B05X A16.
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
Time frame: 90 days after the intervention
Comparison of the elevation of Troponin I US at 12 and 24 hours after the procedure.
Time frame: 90 days after the intervention
Comparison of 90-day postoperative mortality
Time frame: 90 days after the intervention
Comparison of low cardiac postoperative output event with need for ionotropic drugs in the first 24 hours.
Time frame: 90 days after the intervention
Comparison of AKIN-III acute kidney failure event
Time frame: 90 days after the intervention
Comparison of perioperative AMI incidence
Time frame: 90 days after the intervention
Comparison of major bleeding event or life-threatening or disabling hemorrhage.
Time frame: 90 days after the intervention
Comparison of the need for transfusion of blood products (absolute number) in the first 48 hours.
Time frame: 90 days after the intervention
Comparison of the need for prolonged mechanical ventilation for >24h.
Time frame: 90 days after the intervention
Comparison of type 1 and type 2 neurological complications.
Time frame: 90 days after the intervention
Comparison of the incidence of postoperative atrial fibrillation.
Time frame: 90 days after the intervention
Comparison of overall survival at 90 days.
Contact information is provided by the study sponsor or research team.
Lourdes Montero Cruces
Other
Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery with Extracorporeal Circulation. CARDIO-HEART Clinical Trial.
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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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