- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02571920
Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA) (EMOA)
Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA Study)
Обзор исследования
Статус
Подробное описание
The perioperative management in cardiac surgery patients has changed dramatically in the last fifteen years with the development of new cardiac output monitoring devices, the availability of new inotropic molecules, and a modern treatment for cardio-circulatory failure.
However, few studies report the possible changes in practice. The last French national survey was conducted in 2001. Since then, the literature is poor on the subject, and the impact of new approaches has been only marginally addressed. Recently, a German postal survey was conducted among cardiac surgery anesthesiologists, but on purely declarative elements and without patient data.
The investigators offer a type of national prospective observational study to evaluate professional practices, morbidity and mortality in cardiac surgical patients. This study must include all patients undergoing cardiac surgery at the participating centers during 7 weeks.
The main objective of this work is to assess the proportion of patients undergoing cardiac surgery receiving a cardiac output monitoring.
Secondary objectives are to describe the relationship between the use of cardiac output monitoring and the use of positive inotropic agents and vasoactive (type molecules, duration), volume expansion and transfusions the first 24 hours, and the incidence postoperative complications for patients undergoing cardiac surgery.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Caen, Франция
- Caen University hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Patients over 18 years old undergoing cardiac surgery during the study period
Non-inclusion Criteria:
- age under 18 years old
- Extracorporeal life support and others cardiac assistance
- congenital cardiac surgery
- TAVI procedures
- Pericardium surgical drainages
- Sternal sepsis surgery
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: Когорта
- Временные перспективы: Перспективный
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Proportion of patients undergoing cardiac surgery and receiving a cardiac output monitoring.
Временное ограничение: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Correlation between use of cardiac output monitoring and the incidence of norepinephrine use
Временное ограничение: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
|
Correlation between use of cardiac output monitoring and the incidence of dobutamine use
Временное ограничение: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
|
Correlation between use of cardiac output monitoring and the incidence of epinephrine use
Временное ограничение: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
|
Correlation between use of cardiac output monitoring and the length of norepinephrine infusion
Временное ограничение: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
|
Correlation between use of cardiac output monitoring and the length of dobutamine infusion
Временное ограничение: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
|
Correlation between use of cardiac output monitoring and the length of epinephrine infusion
Временное ограничение: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
|
Correlation between use of of cardiac output monitoring and the incidence of red blood cell transfusion
Временное ограничение: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
|
Correlation between use of of cardiac output monitoring and the volume of fluid expansion during first day following cardiac surgery
Временное ограничение: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
|
Correlation between use of of cardiac output monitoring and the incidence of postoperative complications
Временное ограничение: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Marc-Olivier Fischer, University Hospital, Caen
- Главный следователь: Fabien Dechanet, University Hospital, Caen
- Главный следователь: Raphaël D'Orlando, University Hospital, Caen
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- A14-D64-VOL.23
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