Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course
24 de mayo de 2018 actualizado por: Claudia Spies
Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course - a Pilot Study
A single- center prospective observational study.
This study evaluates different aspects of endothelial function.
It investigates the endothelial leakage with the venous occlusion plethysmography and the flow-mediated vasodilatation by ischaemia reperfusion testing.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
47
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
-
-
-
Berlin, Alemania, 13353
- Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
-
-
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
Sí
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra de probabilidad
Población de estudio
Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin
Descripción
Inclusion Criteria:
- Offered patient information and written informed consent
Female patients aged greater than or equal to 18 years:
- for reduction of a primary ovarian tumour or recidive of an ovarian tumour
pregnant patients with:
- clinical normal pregnancy
- pregnancy with weight gain of more than 10 kg
- pregnancy and gestosis
- healthy volunteers
Exclusion Criteria:
- Persons without the capacity to consent
- Unability of German language use
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
- (Unclear) history of alcohol or substances disabuse
- Coworker of the Charité
- Advanced disease of the oesophagus or upper respiratory tract
- Operation in the area of the oesophagus or nasopharynx within the last two months
- Neurological or psychiatric disease
- CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospital stay
- American Society of Anaesthesiologists (ASA) classification greater than IV
- Renal insufficiency (dependency of haemodialysis)
- Pulmonal oedema in thorax x-ray
- History of intracranial hemorrhage within one year of participation in the study
- Conditions following venous thrombosis within the last three years before study inclusion
- Inflammatory or reflective disease of blood vessels (Raynaud-Syndrome, Vasculitis)
- Inherent connective tissue disease(e.g. Marfan Syndrome)
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 |
|---|
|
Perioperative ovarian cancer patients
|
|
Pregnant patients
|
|
Female healthy volunteers
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Filtration coefficient
Periodo de tiempo: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Endothelial parameter from the examination with venous occlusion plethysmography.
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
Filtration coefficient
Periodo de tiempo: up to one hour single measurement in pregnant woman
|
Endothelial parameter from the examination with venous occlusion plethysmography.
|
up to one hour single measurement in pregnant woman
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
All patients: Hemodynamic parameters
Periodo de tiempo: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
|
All patients: Markers of endothelial dysfunction (ICAM-1, E-Selectin, vWF)
Periodo de tiempo: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
|
All patients: Endothelial flow-mediated vasodilatation
Periodo de tiempo: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
|
Perioperative patients: Blood loss
Periodo de tiempo: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
|
Perioperative patients: Parameter of monitored sedation (BIS - Monitoring)
Periodo de tiempo: during the operation
|
during the operation
|
|
|
Perioperative patients: Incidence and impact of organ dysfunctions
Periodo de tiempo: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
|
Perioperative patients: Pain
Periodo de tiempo: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
Perioperative patients: Body weight
Periodo de tiempo: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
|
Perioperative patients: Satisfaction of the patients, surgeon and anesthesiologist
Periodo de tiempo: on the day of surgery
|
on the day of surgery
|
|
|
Perioperative patients: Duration until clinical discharge criteria were satisfied
Periodo de tiempo: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Postanesthesia Discharge Scoring System (PADS) for Determining Home-Readiness
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
Perioperative patients: Intensive care unit average length of stay; hospital average length of stay
Periodo de tiempo: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
|
|
Perioperative patients: Quality of life
Periodo de tiempo: perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks
|
Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of three responses.
The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension.
|
perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks
|
|
Pregnant patients: History data of the pregnancy, parameter of Gestosis
Periodo de tiempo: up to one hour single measurement in pregnant woman
|
Gestosis: toxemia of pregnancy
|
up to one hour single measurement in pregnant woman
|
|
All patients: Immunological Markers
Periodo de tiempo: perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Differences in selected immunologic parameters among others IL-6, IL-10
|
perioperatively up to the fifth postoperative day in patients undergoing surgery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
29 de marzo de 2011
Finalización primaria (Actual)
29 de septiembre de 2012
Finalización del estudio (Actual)
29 de septiembre de 2012
Fechas de registro del estudio
Enviado por primera vez
8 de marzo de 2011
Primero enviado que cumplió con los criterios de control de calidad
8 de marzo de 2011
Publicado por primera vez (Estimar)
9 de marzo de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de mayo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
24 de mayo de 2018
Última verificación
1 de mayo de 2018
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- POPEYE
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .