Comparison between Solutions that protect the heart through biopsy and laboratory tests during cardiac surgery.

Not Applicable

Recruiting

• Conditions: Comparison between Custodiol, del Nido and del Nido modified cardioplegic solutions in myocardial protection with tissue and laboratory analysis during cardiopulmonary bypass of adult patients undergoing cardiac surgery.Heart Arrest, Induced; Extracorporeal Circulation; Cardiovascular Surgical Procedures; Pathology; Cardiovascular diseases.

• Registration Number: RBR-997tqhh
• Lead Sponsor: Hospital Nossa Senhora da Conceição

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-26
• Study Completion: 2022-12-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

All patients who underwent valve replacement surgery or myocardial revascularization with cardiopulmonary bypass at Hospital Nossa Senhora da Conceição, Porto Alegre, aged 18 years or over, in accordance with the Free and Informed Consent Form (Annex B), as Resolution 196/6, of June 13, 1988, of the National Health Council

Exclusion Criteria

Previous cardiac surgery; Chronic renal failure (serum creatinine greater than 1.5 mg/dL); Serious psychiatric illness; Urgency or emergency; Multiple surgeries.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to assess myocardial protection between the 3 cardioplegic solutions through an anatomopathological examination of the epicardium for the analysis of cellular structural changes.

Secondary Outcome Measures

Name	Time	Method
Assessments of additional myocardial protection measures: ventricular fibrillation after opening the aortic clamp, changes in the postoperative ejection fraction, length of time using vasopressors or inotropic solutions and the need for hemodynamic support with an intra-aortic balloon.;Intraoperative results: total cardioplegia volume and number of doses, total aortic clamp time and extra-corporeal circulation.;Clinical outcomes: length of stay in the intensive care unit, incidence of<br>postoperative atrial fibrillation or flutter, AMI, mortality and transfusions of blood products.;Comparisons between cardioplegic solutions regarding the prediction of major cardiovascular events in adult patients undergoing cardiac surgery.;Compare the cost-effectiveness ratio between the solutions.;Assessments myocardial protection through the serum levels of cardiac enzymes (CK, CK-MB and troponin)in the immediate postoperative period and 12 and 24 hours after the end of pulmonary bypass.