Prevention and Treatment of Hemodialysis Vascular Access Malfunction
Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses.
It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. Moreover, once accesses at potential risk are identified, it is not well established which method of intervention, Surgery vs. Angioplasty vs. Expectant Management, is superior in terms of clinical and financial outcome. The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subjects with End Stage Renal Disease on chronic maintenance hemodialysis 3 times per week
- Have an arteriovenous (polytetrafluoroethylene) graft as vascular access
- Have a venous stenosis between 30% and 70% as determined by angiogram
Exclusion Criteria:
- Native arteriovenous fistula
- Known previous vascular accesses complications, such as central vein stenosis, and multiple access surgeries >4
- Unwilling to participate
- Allergy to iodine
- Absolute contraindication for surgery (e.g. medical condition precludes anesthesia and surgery)
- Known arterial limb stenosis or long vessel length venous stenosis which are unamenable to surgical or angioplasty techniques, respectively, and therefore prohibit randomization
- Known hypercoagulable state
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: 1
control group
|
|
|
Comparador activo: 2
angioplasty intervention
|
angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist
|
|
Comparador activo: 3
surgery intervention
|
surgical revision of patient's PTFE in a timely fashion not to exceed 72-96 hours after the angiogram; method of revision to be determined by the surgeon performing the procedure
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
To test the hypothesis that early intervention of a vascular access determined to be at increased risk of malfunction and thrombosis improves the long-term access outcome versus standard of care.
Periodo de tiempo: 2 years
|
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous.
Periodo de tiempo: 2 years
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Talat A Ikizler, MD, Vanderbilt University Medical Center
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 9318
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