- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01294930
Indicators of Operative and Postoperative Complications in Patients Operated for Hip Fracture (IOPC)
Patients operated for hip fractures are older and have several conditions that have negative influences on the perioperative and postoperative prognosis.
Hip fractures can also be painful, which is stressful for the physiology of the patient. Many old patients have received to little fluid intake. They often have diuretic therapy, which even worsens dehydration/hypovolemia.
Some patients have to wait several days for surgery. Several studies have shown a high degree of complications and an increased mortality in this patient group.
Early preoperative optimization can improve the outcome. The available methods for optimization of the patient are complicated and time consuming.
The investigators wish with this study to try new approaches to find which patients still are dehydrated when they come to the operation ward.
The aim is to measure the color and density of the urine as well as to register the the variability in the plethysmographic curve before spinal anaesthesia.
These results will be compared to circulatory instability during and after surgery as well as to postoperative complications.
Descripción general del estudio
Descripción detallada
All patients with hip fractures planed fore surgery at the Hospital in Norrkoping will come into consideration to participate in study.
Many will however not be able to give consent. These will not be included in the study.
Directly preoperatively urine will be collected. Color and density will be measured/registered.
The pulseoximeter reading will be registered (Saturation, pulse, PI and PVI) before spinal anaesthesia and after spinal anaesthesia as well as during the surgery.
Two to three days postoperatively a follow up will be performed, to register complications (Circulatory instability, confusion, infection, affected kidney function/creatinine rise).
30 day postoperative mortality will also be controlled.
These results will be compared, to see if pulse oximeter readings or urine concentration can predict complications.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Norrkoeping, Suecia
- Anaesthesia dept, Vrinnevisjukhuset
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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 with hip fracture
- operation for the hip fracture
- informed consent
Exclusion Criteria:
- patients not giving consent
- patients not being able to understand information
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
hip fracture
Patients operated for hip fracture, giving informed consent
|
measurement of urine color, density and plethysmographic variability index before and during surgery.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
mortality
Periodo de tiempo: 30 days
|
30-day mortality related to indices of dehydration (urine and pulse oximetry)
|
30 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
operative and postoperative complications
Periodo de tiempo: 3 days
|
Number of complications according to a prospective list
|
3 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Robert Hahn, MD PhD Prof, University Hospital, Linkoeping
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IOPC
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. .