- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Caen, Francia
- Caen University hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Proportion of patients undergoing cardiac surgery and receiving a cardiac output monitoring.
Periodo de tiempo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Correlation between use of cardiac output monitoring and the incidence of norepinephrine use
Periodo de tiempo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of cardiac output monitoring and the incidence of dobutamine use
Periodo de tiempo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of cardiac output monitoring and the incidence of epinephrine use
Periodo de tiempo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of cardiac output monitoring and the length of norepinephrine infusion
Periodo de tiempo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of cardiac output monitoring and the length of dobutamine infusion
Periodo de tiempo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of cardiac output monitoring and the length of epinephrine infusion
Periodo de tiempo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of of cardiac output monitoring and the incidence of red blood cell transfusion
Periodo de tiempo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of of cardiac output monitoring and the volume of fluid expansion during first day following cardiac surgery
Periodo de tiempo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of of cardiac output monitoring and the incidence of postoperative complications
Periodo de tiempo: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marc-Olivier Fischer, University Hospital, Caen
- Investigador principal: Fabien Dechanet, University Hospital, Caen
- Investigador principal: Raphaël D'Orlando, University Hospital, Caen
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- A14-D64-VOL.23
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