Stroke Volume Analysis During Aortic Valve Replacement Trial (standart)
7 de agosto de 2014 actualizado por: Michael Sander, Charite University, Berlin, Germany
Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure.
Insufficient stroke volume and/or cardiac output due to hypovolemia or cardiac defects play a central role in causing poor peripheral tissue oxygenation.
In order to assess stroke volume, there are numerous invasive and non-invasive methods available.
Up to the present date it is unknown, if these methods may by used interchangeably in patients with severe cardiac defects like aortic stenosis.
Descripción general del estudio
Estado
Desconocido
Condiciones
Tipo de estudio
De observación
Inscripción (Anticipado)
68
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 10117
- Reclutamiento
- Charité Universitätsmedizin Berin
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Sub-Investigador:
- Felix Balzer, MD
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Contacto:
- Michael Sander, MD
- Número de teléfono: +4930450531052
- Correo electrónico: michael.sander@charite.de
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Sub-Investigador:
- Sascha Treskatsch, MD
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Sub-Investigador:
- Marit Habicher, MD
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Sub-Investigador:
- Viktor Mezger, MD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Cardiac surgery at a university hospital
Descripción
Inclusion Criteria:
- scheduled transcatheter aortic valve implantation
- signed patient consent form
- aged 18 or older by time of surgery
- no participation in other clinical trials
Exclusion Criteria:
- pregnant or breast-feeding women
- emergency surgery
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Hemodynamic optimisation
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No hemodynamic optimisation
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Measurement of stroke volume (ml) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter
Periodo de tiempo: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Measurement of cardiac output (l/min) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter
Periodo de tiempo: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Measurement of stroke volume (ml) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter
Periodo de tiempo: After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Accordance of stroke volume and cardiac output measurements assessed by (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter AFTER ADMINISTRATION OF FLUID BOLUS
Periodo de tiempo: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Accordance of stroke volume and cardiac output measurements assessed by two of the mentioned methods [i.e. (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter]
Periodo de tiempo: Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
|
Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
|
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Measurement of cardiac output (l/min) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter
Periodo de tiempo: After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
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oxygen delivery (ml)
Periodo de tiempo: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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image quality of echocardiography
Periodo de tiempo: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Length of stay on ICU
Periodo de tiempo: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Cumulative rate of infections
Periodo de tiempo: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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incidence of delirium after surgery
Periodo de tiempo: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
|
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dosage of inotropic medication (mg/d)
Periodo de tiempo: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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length of hospital stay
Periodo de tiempo: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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incidence of stroke
Periodo de tiempo: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Michael Sander, MD, Charite University, Berlin, Germany
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2014
Finalización primaria (Anticipado)
1 de mayo de 2015
Fechas de registro del estudio
Enviado por primera vez
20 de mayo de 2014
Primero enviado que cumplió con los criterios de control de calidad
2 de junio de 2014
Publicado por primera vez (Estimar)
5 de junio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de agosto de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
7 de agosto de 2014
Última verificación
1 de agosto de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- EA1/060/13
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