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

Comparison between Long term Cardioplegic Solutions in Myocardial protection with Tissue and Laboratory Analysis: Randomized Doubleblind Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-997tqhh
Enrollment
Unknown
Registered
2022-01-26
Start date
2021-06-01
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

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

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 100 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 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.

Countries

Brazil

Contacts

Public ContactKathize Lira
kathizelira@hotmail.com+55-047-999250679

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 7, 2026