Comparison between Custodiol®, del Nido, and modified del Nido in myocardial protection – CARDIOPLEGIA Trial: a randomized double-blind clinical trial
Phase 4
Recruiting
- Conditions
- Troponin, creatine kinase, blood glucose, blood gas, electrolytes, C-reactive protein, lactate, blood count, total cardioplegia volume and number of doses, total aortic clamp time and extra-corporeal circulation, arrhythmias, acute myocardial infarction, need for hemodynamic support with an intra-aortic balloon, length of time using vasopressors or inotropic solutions, length of stay in the intensive care unit, transfusions of blood products, changes in the postoperative ejection fraction, mortality
- Registration Number
- RBR-7g5s66
- Lead Sponsor
- Hospital Nossa Senhora da Conceição
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Patients referred for elective valve replacement surgery or coronary artery bypass grafting surgery (CABG) with cardiopulmonary bypass, aged at least 18 years, accordance with the Free and Informed Consent Form, will be enrolled.
Exclusion Criteria
Patients with chronic renal disease (previous medical diagnosis or serum creatinine greater than 1.5 mg/dL), previous cardiac surgery, severe psychiatric illness, or inability or unwillingness to give informed consent for participation will be excluded.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression of the cardiac enzymes curve (CK, CK-MB and troponin), determined through laboratory evaluation of arterial blood samples collected in the preoperative period and at 2, 12 and 24 hours after the end of the extracorporeal circulation.
- Secondary Outcome Measures
Name Time Method