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Comparison between Custodiol®, del Nido, and modified del Nido in myocardial protection – CARDIOPLEGIA Trial: a randomized double-blind clinical trial

Comparison between Custodiol®, del Nido, and modified del Nido in the myocardial protection – CARDIOPLEGIA Trial: a randomized double-blind clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-7g5s66
Enrollment
Unknown
Registered
2020-07-06
Start date
2020-07-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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, morta

Interventions

Ninety patients will be randomized to receive the solutions of del Nido, del Nido modified with ringer lactate or Brestschneider during cardiopulmonary bypass, 30 for each group. An arterial blood sam

Sponsors

Hospital Nossa Senhora da Conceição
Lead Sponsor
Hospital Nossa Senhora da Conceição
Collaborator

Eligibility

Age
18 Years to 110 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Intraoperative outcomes: total volume of cardioplegia and number of doses, total aortic cross-clamp time, and cardiopulmonary bypass;;Assessments of additional myocardial protection measures: incidence of ventricular fibrillation requiring electrical defibrillation after aortic cross-clamp removal, postoperative changes in the left ventricular ejection fraction (LVEF) and in the ventricular septal function, blood gas analysis, duration of inotrope or vasopressor requirement, and requirement for intra-aortic balloon pump (IABP) support. ;Clinical outcomes: ICU (intensive care unit) stay, prolonged ventilation (>24 h), incidence of postoperative atrial fibrillation or flutter, acute myocardial infarction, mortality, and blood products transfusion;;Progression of the gasometry and CBC elements curve, lactate, C-reactive protein, glycemia and electrolytes, determined through laboratory evaluation of arterial blood samples collected preoperatively and at 2, 12 and 24 hours after the end of extracorporeal circulation. corporeal.;Compare the cost-effectiveness ratio between the solutions.; Comparisons between cardioplegic solutions regarding the prediction of major cardiovascular events in adult patients undergoing cardiac surgery.

Countries

Brazil

Contacts

Public ContactAdriana Almeida

Hospital Nossa Senhora da Conceição

adrianasdealmeida@gmail.com+55-051-996510255

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 14, 2026