TROMETAMOL, SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM CITRATE, GLUCOSE MONOHYDRATE, CITRIC ACID MONOHYDRATE for Cardiovascular surgery

Inclusion criteria

• {"criterion_text":"-Patients over 18 years of age."}
• {"criterion_text":"-Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping."}

Exclusion criteria

• {"criterion_text":"-1. Pregnancy."}
• {"criterion_text":"-2. Aortic arch procedures."}
• {"criterion_text":"-3. Procedures in which hypothermia <28ºC is expected during the intervention."}
• {"criterion_text":"-4. Minimally invasive procedures “Port Access”."}
• {"criterion_text":"-5. Active endocarditis."}
• {"criterion_text":"-6. Emerging procedures."}
• {"criterion_text":"-7. Isolated aortic valve replacements."}
• {"criterion_text":"-8. Decision of the main surgeon not to participate in the study due to other clinical criteria."}

Primary endpoints

• {"endpoint_text":"-a)\tComparison of the composite event of death, perioperative AMI, low cardiac postoperative output with need for ionotropics, and AKIN-III acute kidney failure in patients administered Custodiol crystalloid cardioplegia and Buckberg hematic cardioplegia 90 days after the intervention.","definition_or_measurement_approach":"Composite event assessed at 90 days after the intervention, comprising death, perioperative acute myocardial infarction (AMI), low postoperative cardiac output requiring ionotropic support, and AKIN-III acute kidney failure."}

Secondary endpoints

• {"endpoint_text":"-a)\tComparison of the elevation of Troponin I US at 12 and 24 hours after the procedure.","definition_or_measurement_approach":"Troponin I US levels measured at 12 and 24 hours post-procedure; comparison between groups."}
• {"endpoint_text":"-b)\tComparison of 90-day postoperative mortality.","definition_or_measurement_approach":"Postoperative mortality measured at 90 days after intervention; comparison between groups."}
• {"endpoint_text":"-c)\tComparison of low cardiac postoperative output event with need for ionotropic drugs in the first 24 hours.","definition_or_measurement_approach":"Occurrence of low cardiac output requiring ionotropic drugs within first 24 hours post-procedure; comparison between groups."}
• {"endpoint_text":"-d)\tComparison of AKIN-III acute kidney failure event.","definition_or_measurement_approach":"Occurrence of AKIN-III acute kidney failure post-procedure; comparison between groups."}
• {"endpoint_text":"-e)\tComparison of perioperative AMI incidence.","definition_or_measurement_approach":"Incidence of perioperative acute myocardial infarction; comparison between groups."}
• {"endpoint_text":"-f)\tComparison of major bleeding event or life-threatening or disabling hemorrhage.","definition_or_measurement_approach":"Incidence of major bleeding or life-threatening/disabling hemorrhage; comparison between groups."}
• {"endpoint_text":"-g)\t Comparison of the need for transfusion of blood products (absolute number) in the first 48 hours.","definition_or_measurement_approach":"Absolute number of blood product transfusions within first 48 hours post-procedure; comparison between groups."}
• {"endpoint_text":"-h)\tComparison of the need for prolonged mechanical ventilation for >24h.","definition_or_measurement_approach":"Requirement for mechanical ventilation >24 hours post-procedure; comparison between groups."}
• {"endpoint_text":"-i)\tComparison of type 1 and type 2 neurological complications.","definition_or_measurement_approach":"Incidence of type 1 and type 2 neurological complications; comparison between groups."}
• {"endpoint_text":"-j)\tComparison of the incidence of postoperative atrial fibrillation.","definition_or_measurement_approach":"Incidence of postoperative atrial fibrillation; comparison between groups."}
• {"endpoint_text":"-k)\tComparison of overall survival at 90 days.","definition_or_measurement_approach":"Overall survival assessed at 90 days post-intervention; comparison between groups."}

Spain

Earliest CTIS Part Ii Submission Date

06-05-2024

Latest Decision Or Authorization Date

03-06-2024

Processing Time Days

28

Number Of Sites

1

Number Of Participants

600

Primary sponsor

Full Name

Hospital Clinico San Carlos

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain