Myocardial protection: comparing histological effects of single-dose cardioplegic solutions-study protocol for a secondary analysis of the CARDIOPLEGIA trial.

Bretschneider cardioplegic solution Myocardial protection cardioplegic solutions custodiol solution del Nido solution

Journal

Journal of thoracic disease
ISSN: 2072-1439
Titre abrégé: J Thorac Dis
Pays: China
ID NLM: 101533916

Informations de publication

Date de publication:
29 Feb 2024
Historique:
received: 14 09 2023
accepted: 15 12 2023
medline: 20 3 2024
pubmed: 20 3 2024
entrez: 20 3 2024
Statut: ppublish

Résumé

Myocardial protection is crucial for successful cardiac surgery, as it prevents heart muscle damage that can occur during the procedure. Prolonged hypoxia without proper protection can lead to adenosine triphosphate consumption, microvilli loss, blister formation, and edema. Custodiol, del Nido, and modified del Nido are single-dose cardioplegic solutions with proven safety and significance in modern surgery. While each has been independently assessed for patient outcomes, limited research directly compares them. This study aims to compare their myocardial protection using histological analysis. In a double-blind clinical trial, at least 90 patients will be randomly assigned to receive one of the three cardioplegic solutions. Myocardial biopsies will be collected before cardiopulmonary bypass and 15 minutes after reperfusion. The surgical, anesthetic and perfusion techniques will be the same for all patients, following the Institution's standard protocols. The ideal cardioplegic solution does not exist, and its selection remains challenging for surgeons. In modern surgical practice, understanding the behavior of these solutions and the ischemic tissue damage caused during induced cardiac arrest allows for safer surgical procedures. The results of this clinical trial can help in understanding the behavior of cardioplegic solutions and their tissue effects. Thus, by selecting the best cardioplegic solution, ischemic damage can be minimized, enhancing the effectiveness of this essential technique in cardiac procedures. The study may aid in implementing clinical protocols in several institutions, aiming to choose the solution with a superior myocardial protection profile, increasing safety, and reducing expenses. Brazilian Clinical Trials Registry (ReBEC, http://ensaiosclinicos.gov.br/): RBR-997tqhh. Registered: January 26th, 2022.

Sections du résumé

Background UNASSIGNED
Myocardial protection is crucial for successful cardiac surgery, as it prevents heart muscle damage that can occur during the procedure. Prolonged hypoxia without proper protection can lead to adenosine triphosphate consumption, microvilli loss, blister formation, and edema. Custodiol, del Nido, and modified del Nido are single-dose cardioplegic solutions with proven safety and significance in modern surgery. While each has been independently assessed for patient outcomes, limited research directly compares them. This study aims to compare their myocardial protection using histological analysis.
Methods UNASSIGNED
In a double-blind clinical trial, at least 90 patients will be randomly assigned to receive one of the three cardioplegic solutions. Myocardial biopsies will be collected before cardiopulmonary bypass and 15 minutes after reperfusion. The surgical, anesthetic and perfusion techniques will be the same for all patients, following the Institution's standard protocols.
Discussion UNASSIGNED
The ideal cardioplegic solution does not exist, and its selection remains challenging for surgeons. In modern surgical practice, understanding the behavior of these solutions and the ischemic tissue damage caused during induced cardiac arrest allows for safer surgical procedures. The results of this clinical trial can help in understanding the behavior of cardioplegic solutions and their tissue effects. Thus, by selecting the best cardioplegic solution, ischemic damage can be minimized, enhancing the effectiveness of this essential technique in cardiac procedures. The study may aid in implementing clinical protocols in several institutions, aiming to choose the solution with a superior myocardial protection profile, increasing safety, and reducing expenses.
Trial Registration UNASSIGNED
Brazilian Clinical Trials Registry (ReBEC, http://ensaiosclinicos.gov.br/): RBR-997tqhh. Registered: January 26th, 2022.

Identifiants

pubmed: 38505015
doi: 10.21037/jtd-23-1442
pii: jtd-16-02-1480
pmc: PMC10944752
doi:

Types de publication

Journal Article

Langues

eng

Pagination

1480-1487

Informations de copyright

2024 Journal of Thoracic Disease. All rights reserved.

Déclaration de conflit d'intérêts

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-23-1442/coif). The authors have no conflicts of interest to declare.

Auteurs

Kathize Betti Lira (KB)

Department of Cardiovascular Surgery-Postgraduate Program in Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.
Department of Education and Research-Postgraduate Program in Technology Assessment for the Brazilian National Health System, Conceição Hospital Group, Porto Alegre, RS, Brazil.

Renan Senandes Delvaux (RS)

Department of Cardiovascular Surgery-Postgraduate Program in Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.

Felipe Abatti Spadini (FA)

Department of Cardiovascular Surgery-Postgraduate Program in Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.
Department of Education and Research-Postgraduate Program in Technology Assessment for the Brazilian National Health System, Conceição Hospital Group, Porto Alegre, RS, Brazil.

Luis Henrique Hauschild (LH)

Department of Cardiovascular Surgery-Postgraduate Program in Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.
Department of Education and Research-Postgraduate Program in Technology Assessment for the Brazilian National Health System, Conceição Hospital Group, Porto Alegre, RS, Brazil.

Rafael Oliveira Ceron (RO)

Department of Cardiovascular Surgery-Postgraduate Program in Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.
Department of Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.

Fernando Anschau (F)

Department of Education and Research-Postgraduate Program in Technology Assessment for the Brazilian National Health System, Conceição Hospital Group, Porto Alegre, RS, Brazil.
Health Technology Assessment Center, Conceição Hospital Group, Porto Alegre, RS, Brazil.

Luciane Kopittke (L)

Department of Education and Research-Postgraduate Program in Technology Assessment for the Brazilian National Health System, Conceição Hospital Group, Porto Alegre, RS, Brazil.
Health Technology Assessment Center, Conceição Hospital Group, Porto Alegre, RS, Brazil.

Juarez Rode (J)

Department of Cardiovascular Surgery-Postgraduate Program in Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.
Department of Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.

Rafael Antônio Widholzer Rey (RAW)

Department of Cardiovascular Surgery-Postgraduate Program in Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.
Department of Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.

Estefania Inez Wittke (EI)

Department of Cardiovascular Surgery-Postgraduate Program in Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.
Department of Education and Research-Postgraduate Program in Technology Assessment for the Brazilian National Health System, Conceição Hospital Group, Porto Alegre, RS, Brazil.
Department of Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.

Alfeu Roberto Rombaldi (AR)

Department of Cardiovascular Surgery-Postgraduate Program in Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.
Department of Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.

Eduardo Cambruzzi (E)

Department of Pathology, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.

Eron Rodrigues Cunha Lopes (ERC)

Department of Pathology, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.

Adriana Silveira Almeida (AS)

Department of Cardiovascular Surgery-Postgraduate Program in Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.
Department of Education and Research-Postgraduate Program in Technology Assessment for the Brazilian National Health System, Conceição Hospital Group, Porto Alegre, RS, Brazil.
Department of Cardiovascular Surgery, Nossa Senhora da Conceição Hospital, Porto Alegre, RS, Brazil.
Health Technology Assessment Center, Conceição Hospital Group, Porto Alegre, RS, Brazil.

Classifications MeSH