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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
600
Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia.
Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia.
Hospital Clínico San Carlos
Madrid, Madrid, Spain
RECRUITINGComparison 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
Time frame: 90 days after the intervention
Differences in the incidence of elevation of Troponin
Comparison of the elevation of Troponin I US at 12 and 24 hours after the procedure.
Time frame: 90 days after the intervention
Differences in the 90-day mortality rate
Comparison of 90-day postoperative mortality
Time frame: 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.
Time frame: 90 days after the intervention
Differences in the incidence of acute kidney failure event
Comparison of AKIN-III acute kidney failure event
Time frame: 90 days after the intervention
Differences in the incidence of acute myocardial infarction
Comparison of perioperative AMI incidence
Time frame: 90 days after the intervention
Differences in the incidence of major bleeding event
Comparison of major bleeding event or life-threatening or disabling hemorrhage.
Time frame: 90 days after the intervention
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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.
Time frame: 90 days after the intervention
Differences in the incidence of prolonged mechanical ventilation
Comparison of the need for prolonged mechanical ventilation for \>24h.
Time frame: 90 days after the intervention
Differences in the incidence of neurological complications
Comparison of type 1 and type 2 neurological complications.
Time frame: 90 days after the intervention
Differences in the incidence of postoperative atrial fibrillation.
Comparison of the incidence of postoperative atrial fibrillation.
Time frame: 90 days after the intervention
Differences in the overall survival rate at 90 days.
Comparison of overall survival at 90 days.
Time frame: 90 days after the intervention