Dry Weight Reduction Intervention Via Extra Ultrafiltration (DRIVE-UF)
Most patients who receive hemodialysis treatments have excess fluid in their body that has slowly built up over the course of kidney disease. This extra fluid is the main cause of high blood pressure in dialysis and leads to stress on the heart and lungs.that causes debilitating symptoms and frequent hospitalizations.
This trial will test whether a focused program of 4 or 8 weeks of extra ultrafiltration treatments can remove most of this extra fluid. We believe that getting rid of large amounts of extra fluid will result in sustained improvements in blood pressure and symptoms. Ultrafiltration is a gentler type of dialysis that removes fluid but does not clean the blood.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a randomized trial of patients who are receiving in-center hemodialysis treatments for end stage kidney disease and have clinical suspicion of fluid overload. Enrolled participants will be randomly assigned in 1:1:1 fashion to either a four-week ultrafiltration strategy, an eight-week ultrafiltration strategy, or continuation of their regular thrice weekly hemodialysis treatments. Each ultrafiltration strategy will add two extra four-hour ultrafiltration treatments per week plus pharmacist-guided tapering of blood pressure medications. We will test the impact of these strategies on primary outcomes of
- Change in 24-hour continuous ambulatory blood pressure from baseline to 24-weeks
- Change in symptoms of congestion from baseline to 24-weeks We will also test the impact of the treatment strategies on related symptoms, physical activity levels, hemodynamics. and measures of safety.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ernest Ayers, MSPH
- Número de teléfono: 206-685-1423
- Correo electrónico: ayerse@uw.edu
Copia de seguridad de contactos de estudio
- Nombre: Luisa Rios-Avila
- Número de teléfono: 206-258-9325
- Correo electrónico: lrios1@uw.edu
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98112
- Northwest Kidney Centers
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Contacto:
- Luisa Rios-Avila
- Número de teléfono: 2062589325
- Correo electrónico: lrios1@uw.edu
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Receiving thrice weekly in-center hemodialysis treatments for end stage kidney disease for at least four weeks and clinical suspicion of volume excess based on either:
Persistent hypertension defined by three consecutive pre-dialysis systolic blood pressures ≥140 mmHg or three consecutive pre-dialysis systolic blood pressures 130-140 mmHg plus use of at least two anti-hypertensive medications that can be tapered.
OR
Symptoms of congestion defined by a 12-item Kidney Modified Kansas City Cardiomyopathy Questionnaire (KM-KCCQ) score <75.
Exclusion Criteria:
- Age <18 years
- Receiving hemodialysis treatments for acute kidney injury
- Receiving hemodialysis treatments for less than four weeks
- Planned switch to peritoneal or home dialysis within next three months
- Current or planned incremental hemodialysis (less than 3 treatments per week)
- Current or planned intensive hemodialysis (four or more treatments per week)
- Scheduled kidney transplantation
- Major cardiovascular or bleeding event within previous 90 days
- Receiving chemotherapy or radiation treatment for cancer
- History of cirrhosis with ascites
- Inability to complete 24-hour ambulatory blood pressure measurement
- Wheelchair dependance or other inability to complete six-minute walk test
- Pre-dialysis systolic blood pressure <100 mmHg
- Scheduled use of midodrine with hemodialysis treatments
- History of non-adherence with dialysis treatments
- Pregnancy
- Institutionalized
- Current or pending enrollment in hospice care
- Inappropriate for enrollment based on investigator or nephrologist discretion
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 |
|---|---|
|
Comparador activo: Ultrafiltration sessions for 4 weeks
Two ultrafiltration sessions per week plus pharmacist guided tapering of blood pressure medications in addition to the regular thrice weekly hemodialysis treatments.
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Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.
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Comparador activo: Ultrafiltration sessions for 8 weeks
Two ultrafiltration sessions per week plus pharmacist guided tapering of blood pressure medications in addition to the regular thrice weekly hemodialysis treatments.
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Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.
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Sin intervención: Control arm, no ultrafiltration sessions
Participant receives only their regularly scheduled thrice weekly hemodialysis treatments.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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24-hour continuous ambulatory blood pressure
Periodo de tiempo: Measurement performed at baseline compared to measurement performed at 24 weeks.
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Blood pressure measured continously for a 24-hour period by wearing a blood pressure cuff on the upper arm.
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Measurement performed at baseline compared to measurement performed at 24 weeks.
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Symptoms of congestion.
Periodo de tiempo: Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.
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Change in sypmtoms of congestion caused by fluid overload which we will access by using the Kidney-modified Kansas City Cardiomyopathy Questionnaire.
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Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bryan Kestenbaum, MD, MS, University of Washington
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Insuficiencia renal
- Insuficiencia Renal Crónica
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Hipertensión
- Insuficiencia Renal Crónica
- Edema
- Técnicas de investigación
- Procedimientos quirúrgicos, operativo
- Fenómeno físico
- Filtración
- Técnicas de química, analítica
- Fenómenos químicos
- Circulación extracorpórea
- Ultrafiltración
Otros números de identificación del estudio
- STUDY00025083
- R01DK141693 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
All data and samples will be stored indefinitely for possible future uses. There will be no direct or indirect identifiers stored with the resources after this study is finished.
Resources will be coded with study codes. We plan post de-identified data in public databases such as Dryad at study conclusion.
NIH data sharing policies typically require us to post coded, deidentified individual-level data on one of the preferred platforms. We will work with our NIH project officer to post data after the study is finished to an appropriate platform.
We may collaborate with colleagues and other researchers who demonstrate a legitimate research need for which data and samples from this study would be valuable.
Future uses do not have any restrictions.
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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