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Volume,Sodium and Blood Pressure Management in HD (VSBP)

14 de julio de 2016 actualizado por: Rajiv Saran, University of Michigan

Fluid-Weight, Volume, Sodium, Blood Pressure Management in Hemodialysis by Limiting Intradialytic and Inter-dialytic Exposure to Sodium and Protocol-based Challenge of Post-dialysis Target Weight: A Pilot and Feasibility Trial

The purpose of this study to conduct a pilot, randomized trial in stable HD patients to evaluate the effect of gradual, step-wise reduction of post-hemodialysis target weight, combined with diligent dietary sodium restriction and reduction in dialysate sodium exposure on hydration/volume status and blood pressure (BP) control.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Fluid-weight management is critical for dialysis patients 1, 2. Previous clinical trials have not comprehensively addressed the application of a strategy combining both sodium restriction and a progressive, but gradual challenge of post dialysis target weight for BP and fluid-weight management in hemodialysis (HD). The investigators postulate that a protocolized, stepwise and gradual challenge of post-hemodialysis target weight when combined with diligent dietary sodium restriction <2000mg sodium/day, will lead to better hydration/volume status and BP control in HD patients. A randomized, two parallel arm trial (n=40) among HD patients is proposed, that compares this comprehensive strategy in one group versus 'usual' HD volume/hydration and BP management in the control group. The two primary outcomes are change in volume/hydration status (assessed by bioelectrical impedance analysis-BIA) and change in BP (pre-dialysis in-center readings, home self-monitored readings as well as 44-hour interdialytic BP). Secondary outcomes include change in target post-dialysis weight, slope of on-line relative plasma volume monitoring (using Crit-line monitors), utilization and change, if any, in antihypertensive regimen, change in interdialytic weight gain, objectively assessed salt-appetite, thirst score, frequency of intradialytic hypotension, cramps and duration of post-dialysis fatigue and recovery, time to achievement of dry weight and laboratory parameters (hemoglobin, albumin, brain natriuretic peptide-BNP, aldosterone and hsCRP). The trial will be 14-weeks in duration and will involve comprehensive assessment of study parameters at baseline, middle and end of the trial. It is anticipated that the trial will lead to the the development of a simple and practical approach for volume and BP control in HD patients that will subsequently need to be studied on a larger scale, i.e., a larger, multicenter study with hard endpoints of death and hospitalization.

Tipo de estudio

Intervencionista

Inscripción (Actual)

50

Fase

  • No aplica

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

  • Estados Unidos
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48104
        • University Dialysis Unit
      • Livonia, Michigan, Estados Unidos, 48152
        • University of Michigan Dialyisis Unit

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 a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Stable adult HD patient (age 18-85 years)
  • Usual in-center pre-dialysis systolic blood pressure of ≥130mmHg. For this purpose mean of pre-dialysis sitting blood pressures for the past one month prior to randomization will be applied for evaluation of inclusion criteria.
  • Able and willing to adhere to study protocol

Exclusion Criteria:

  • Recent acute illness (≤1month)
  • Recent hospitalization (≤1month)
  • Any psychological condition that could interfere with compliance with study protocol.
  • Amputation of both lower limbs (due to interference with electric current for BIA measurement)
  • Pacemaker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings), if their presence interfere with appropriate measurements. In such patients consideration will be given to only doing the calf-BIA measurements and not the total body, at the discretion of the investigators.
  • Use of any investigational product or device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
  • Pregnancy or lactation (pregnancy test will be applied only if the patient is in the reproductive age range).
  • Any condition that, in the view of the PI, places the subject at high risk of poor treatment compliance or of not completing the study

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

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Treatment

  1. Lower sodium intervention:

    Dietary sodium restriction of ≤2.0 g/day or ≤85 mmol/day

    Lower dialysate sodium at 137 mmol/L.

  2. Progressive Challenge to Post Dialysis Weight:

The existing target post-HD weight will be progressively challenged by removing additional fluid in small increments.
Conductual: Lower sodium intervention

1. Lower sodium intervention:

  1. Dietary sodium restriction of ≤2.0 g/day or ≤85 mmol/day (approximately >180-200mmol/day in the average American diet). Sodium restriction will be implemented using intensive dietary counseling performed weekly by a registered study dietitian using the motivational interviewing technique.
  2. Lower dialysate sodium at 137 mmol/L, if perchance a different concentration of dialysate is used for the enrolled individual, although this is unlikely in both the UM associated units, where for some time now, dialysate concentration of 137 mmol/L is currently being used as standard practice. Investigators will ensure that this sodium concentration is indeed used for all study participants.
Otro: Progressive Challenge to Post Dialysis Weight
The existing target post-HD weight will be progressively challenged by removing additional fluid in small increments, unless clinical evidence of volume depletion or hypotension precludes this challenge in the intervention arm. To avoid the occurrence of intradialytic hypotension, the ultrafiltration rate shall not exceed15 ml/kg/hour and post dialysis weight will not be reduced by more than 0.5 kg per dialysis session. In some patients, this may warrant prolongation of the treatment time to achieve lowering of target post dialysis weight, and this process of target weight reduction may need to continue up to and through the interim assessment phase (6-8 weeks).
Sin intervención: Control
Usual care in addition to Blood pressure monitoring and and Hydration status monitoring

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood Pressure
Periodo de tiempo: Pre-dialysis BP measure at Baseline, 6 Weeks and 12 weeks. ABPM measured at baseline and 12 Weeks. Home BP measure through out the 12week period on non-dialysis days
Change in blood pressure (pre-dialysis in-center blood pressure readings, ABPM and home BP monitoring)
Pre-dialysis BP measure at Baseline, 6 Weeks and 12 weeks. ABPM measured at baseline and 12 Weeks. Home BP measure through out the 12week period on non-dialysis days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Post-dialysis Weight
Periodo de tiempo: 12weeks
Change in target post-dialysis weight
12weeks
Heart Rate
Periodo de tiempo: 12 weeks
Change in heart rate
12 weeks
Plasma Volume
Periodo de tiempo: 12 Weeks
Slope of relative plasma volume monitoring
12 Weeks
Medication Use
Periodo de tiempo: 12 Weeks
Change in the utilization of antihypertensive medication ( number of medication and dose)
12 Weeks
Interdialytic Weight gain
Periodo de tiempo: 12 Weeks
Change in the mid-week interdialytic weight gain
12 Weeks
Intradialytic Hypotension
Periodo de tiempo: 12 Weeks
Frequency of intradialytic hypotension; defined as drop in systolic blood pressure associated with symptoms suggestive of low blood pressure such as lightheadedness, dizziness, sweating, etc., or decrease in intradialytic systolic blood pressure to less than 90 mmHg.
12 Weeks
Salt Appetite
Periodo de tiempo: Baseline, 6 week and 12 week
A measure of salt taste impairment and preference
Baseline, 6 week and 12 week
Thirst Score
Periodo de tiempo: Baseline, 6 week, 12 weeks
A measure of general thirst.
Baseline, 6 week, 12 weeks
Post-dialysis fatigue
Periodo de tiempo: Baseline, 6 Weeks & 12 Weeks
A measure of post-dialysis fatigue and recovery after each treatment session
Baseline, 6 Weeks & 12 Weeks
Routine Labs
Periodo de tiempo: Baseline and 12Week
o Routine labs including CBC, renal panel, hsCRP and brain natriuretic peptide (BNP). Interdialytic urine collection for residual renal function (urea and creatinine clearance) estimation will be made. Blood and urine samples will be archived for later analysis for biomarkers such as asymmetric dimethyl arginine (ADMA), plasma aldosterone, and urinary neutrophil gelatinase-associated lipocalin (NGAL), respectively
Baseline and 12Week
True Dry Weight
Periodo de tiempo: 12 weeks
Time to achievement of true 'dry weight' (in the intervention arm only)
12 weeks
Hydration Status
Periodo de tiempo: 12 weeks
Change in hydration status, as measured by BIA, using whole body and segmental techniques.
12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Michigan

Colaboradores

Renal Research Institute

Investigadores

  • Investigador principal: Rajiv Saran, MD, University of Michigan

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 septiembre de 2012

Finalización primaria (Actual)

1 de marzo de 2016

Finalización del estudio (Actual)

1 de marzo de 2016

Fechas de registro del estudio

Enviado por primera vez

9 de enero de 2013

Primero enviado que cumplió con los criterios de control de calidad

10 de enero de 2013

Publicado por primera vez (Estimar)

11 de enero de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de julio de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

14 de julio de 2016

Última verificación

1 de julio de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HUM00054879

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. .

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