Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Custodiol Htk Soln, Buckberg Cardi-Braun.
- Кому может быть актуально
- Состояния в реестре: Cardiac Surgery, Cardioplegia, Heart Arrest. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery with Extracorporeal Circulation. CARDIO-HEART Clinical Trial.
Обзор
Phase IV clinical trial of a single-blind, prospective and longitudinal randomized intervention comparing patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia.
Подробное описание
Myocardial protection by administering cardioplegia is a fundamental concept during cardiopulmonary bypass in patients undergoing cardiac surgery. It is a multifactorial strategy, in which cardioplegia is the most important. To date, there is no standardized consensus on the use of cardioplegia in different cardiac surgery procedures, and the best strategy continues to be debated given the wide range available. The choice of the type of cardioplegia should be made on an individual basis, taking into account the surgical procedure and clinical context. The need for a single dose of cardioplegia could favor the use of Custodiol crystaloid cardioplegia in complex cardiac surgeries that require longer extracorporeal circulation time. Both cardioplegia are safe and effective and widely used globally; however, the information provided in the literature is limited, with most of the information coming from retrospective studies.The objective of the present study is to demonstrate the non-inferiority of Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia in patients undergoing major cardiac surgery with extracorporeal circulation with prolonged aortic clamping times.
Вмешательства
- Препарат Custodiol Htk Soln
Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia. - Препарат Buckberg Cardi-Braun
Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia.
Первичные конечные точки
- Comparison of the composite event [Срок оценки: 90 days after the intervention]
Вторичные конечные точки (11)
- Differences in the incidence of elevation of Troponin [Срок оценки: 90 days after the intervention]
- Differences in the 90-day mortality rate [Срок оценки: 90 days after the intervention]
- Differences in the incidence of low cardiac postoperative output [Срок оценки: 90 days after the intervention]
- Differences in the incidence of acute kidney failure event [Срок оценки: 90 days after the intervention]
- Differences in the incidence of acute myocardial infarction [Срок оценки: 90 days after the intervention]
- Differences in the incidence of major bleeding event [Срок оценки: 90 days after the intervention]
- Differences in the incidence of the need of transfusion [Срок оценки: 90 days after the intervention]
- Differences in the incidence of prolonged mechanical ventilation [Срок оценки: 90 days after the intervention]
- Differences in the incidence of neurological complications [Срок оценки: 90 days after the intervention]
- Differences in the incidence of postoperative atrial fibrillation. [Срок оценки: 90 days after the intervention]
- Differences in the overall survival rate at 90 days. [Срок оценки: 90 days after the intervention]
Критерии участия
Критерии включения
- Patients over 18 years of age.
- Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.
Критерии исключения
- Pregnancy.
- Aortic arch procedures.
- Procedures in which hypothermia <28ºC is expected during the intervention.
- Minimally invasive procedures "Port Access".
- Active endocarditis.
- Emerging procedures.
- Isolated aortic valve replacements.
- Decision of the main surgeon not to participate in the study due to other clinical criteria.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Другое
Центры проведения
Испания · 1 центр
- Hospital Clínico San Carlos — Madrid
Идентификаторы
NCT: NCT06530641 · 24/238-EC_M