- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07659197
Usefulness of the VExUS Protocol for Dry-Weight Adjustment in Hemodialysis Patients: The Multicenter VExHD Study (VEX-HD)
Utilidad Del Protocolo VExUS en el Ajuste de Peso Ideal de Los Pacientes en hemodiálisis
The objective of this prospective observational study is to determine the utility of ultrasonographic assessment using the VExUS protocol for dry weight adjustment in clinically euvolemic patients undergoing hemodialysis.
The primary hypothesis is that the assessment of venous congestion by ultrasound may help identify patients who can tolerate increased ultrafiltration, thereby improving blood pressure control.
The comparison group will consist of patients who do not meet the criteria for venous congestion according to the VExUS protocol.
In patients meeting the criteria for venous congestion, the ultrafiltration volume during hemodialysis will be increased.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients receiving maintenance hemodialysis face persistent challenges in achieving optimal volume status, and intravascular congestion is a major contributor to cardiovascular morbidity. Traditional clinical signs have limited diagnostic accuracy for detecting volume excess, as noted in the protocol: "the evaluation of volume status based on classical symptoms and signs… has shown low sensitivity and specificity". Point-of-care ultrasonography (PoCUS) offers a non-invasive and reproducible method to assess congestion, yet the role of the VExUS protocol in guiding dry-weight adjustment has not been systematically evaluated in this population.
This prospective, multicenter study incorporates a structured, repeated assessment of venous congestion over a five-week period. On the mid-week dialysis day, all participants undergo a modified VExUS examination (excluding intrarenal veins), lung ultrasound, and multifrequency bioimpedance. These assessments are repeated weekly for four consecutive weeks, enabling longitudinal characterization of venous congestion and its relationship with ultrafiltration tolerance, interdialytic weight gain, and blood pressure.
Patients classified as congestive according to VExUS Doppler patterns receive a standardized ultrafiltration increase of 0.3 L during the following week, consistent with the protocol statement: "patients classified as congestive will have ultrafiltration increased… reducing dry weight by 0.3 kg during that week". Hemodynamic tolerance is monitored at each dialysis session, including intradialytic blood pressure, symptoms, and the need for nursing interventions. If the patient tolerates the increased ultrafiltration, the adjusted post-dialysis weight is incorporated into the prescribed dry weight. Patients without evidence of venous congestion continue with standard ultrafiltration based solely on interdialytic weight gain.
The study also includes a comprehensive biomarker program. Baseline blood samples are collected on the first mid-week session and repeated at week five, measuring cardiac biomarkers (NT-proBNP, CA-125, troponin), markers of congestion (bioADM, sST2, CD146), and inflammatory mediators (FGF-23, IL-6, IL-18, TNF-α, among others). Samples requiring specialized analysis are processed and stored according to predefined procedures. These data will help explore biological correlates of venous congestion and their evolution during follow-up.
Additional weekly assessments include lung ultrasound quantification of B-lines, bioimpedance-derived fluid status, and pre-dialysis blood pressure. Intradialytic parameters such as relative blood volume changes and hemodynamic tolerance are recorded at every session. At the end of follow-up, changes in prescribed dry weight, blood pressure, and antihypertensive therapy are evaluated.
The primary objective is to determine whether VExUS can serve as a useful adjunct for dry-weight adjustment in hemodialysis patients. Secondary analyses will examine the impact of congestion-guided ultrafiltration on blood pressure, fluid status, and biomarker trajectories. All clinical decisions outside the predefined ultrafiltration adjustment follow routine practice, and the study does not introduce additional therapeutic interventions.
This structured, repeated-measure design may help clarify the dynamic relationship between venous congestion, ultrafiltration tolerance, and volume management in hemodialysis, and inform future strategies for integrating PoCUS-based vascular assessment into standard nephrology care.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Madrid
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Madrid, Madrid, España, 28055
- Hospital Universitario Infanta Leonor
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients over 18 years of age who are currently on hemodialysis (more than 90 days since the start of the program)
- A schedule of three days per week at the centers included in the study
- Signed informed consent
Exclusion Criteria:
- Clinical signs and symptoms of volume overload
- Patients with liver disease (liver cirrhosis, steatosis, portal vein thrombosis)
- Severe tricuspid regurgitation
- Inability to hold one's breath
- Obesity
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: congestive
Patients who have increased ultrafiltration
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In patients meeting the predefined ultrasonographic criteria for venous congestion, the prescribed dry weight will be reduced by 0.3 kg per week, resulting in a corresponding increase in the ultrafiltration volume during hemodialysis sessions.
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Comparador activo: Non-congested
Patients in whom ultrafiltration was not increased
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In patients who do not meet the predefined ultrasonographic criteria for venous congestion, the ultrafiltration prescription will remain unchanged.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Dry weight
Periodo de tiempo: 4 weeks
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To evaluate the usefulness of the VExUS protocol in dry-weight adjustment in hemodialysis patients.
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4 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in systolic blood pressure
Periodo de tiempo: 4 weeks
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Change in systolic and diastolic blood pressure associated with ultrafiltration practices during the study period.
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4 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Zoccali C, Torino C, Tripepi R, Tripepi G, D'Arrigo G, Postorino M, Gargani L, Sicari R, Picano E, Mallamaci F; Lung US in CKD Working Group. Pulmonary congestion predicts cardiac events and mortality in ESRD. J Am Soc Nephrol. 2013 Mar;24(4):639-46. doi: 10.1681/ASN.2012100990. Epub 2013 Feb 28.
- Romero-Gonzalez G, Manrique J, Slon-Roblero MF, Husain-Syed F, De la Espriella R, Ferrari F, Bover J, Ortiz A, Ronco C. PoCUS in nephrology: a new tool to improve our diagnostic skills. Clin Kidney J. 2022 Sep 12;16(2):218-229. doi: 10.1093/ckj/sfac203. eCollection 2023 Feb.
- Flythe JE, Xue H, Lynch KE, Curhan GC, Brunelli SM. Association of mortality risk with various definitions of intradialytic hypotension. J Am Soc Nephrol. 2015 Mar;26(3):724-34. doi: 10.1681/ASN.2014020222. Epub 2014 Sep 30.
- Zoccali C, Torino C, Mallamaci F, Sarafidis P, Papagianni A, Ekart R, Hojs R, Klinger M, Letachowicz K, Fliser D, Seiler-Mussler S, Lizzi F, Wiecek A, Miskiewicz A, Siamopoulos K, Balafa O, Slotki I, Shavit L, Stavroulopoulos A, Covic A, Siriopol D, Massy ZA, Seidowsky A, Battaglia Y, Martinez-Castelao A, Polo-Torcal C, Coudert-Krier MJ, Rossignol P, Fiaccadori E, Regolisti G, Hannedouche T, Bachelet T, Jager KJ, Dekker FW, Tripepi R, Tripepi G, Gargani L, Sicari R, Picano E, London GM. A randomized multicenter trial on a lung ultrasound-guided treatment strategy in patients on chronic hemodialysis with high cardiovascular risk. Kidney Int. 2021 Dec;100(6):1325-1333. doi: 10.1016/j.kint.2021.07.024. Epub 2021 Aug 19.
- Loutradis C, Papadopoulos CE, Sachpekidis V, Ekart R, Krunic B, Papadopoulou D, Papagianni A, Mallamaci F, Zoccali C, Sarafidis PA. Lung ultrasound-guided dry-weight reduction and echocardiographic changes in clinically euvolemic hypertensive hemodialysis patients: 12-month results of a randomized controlled trial. Hellenic J Cardiol. 2022 Mar-Apr;64:1-6. doi: 10.1016/j.hjc.2021.11.002. Epub 2021 Nov 29.
- Loutradis C, Sarafidis PA, Ekart R, Tsouchnikas I, Papadopoulos C, Kamperidis V, Alexandrou ME, Ferro CJ, Papagianni A, London G, Mallamaci F, Zoccali C. Ambulatory blood pressure changes with lung ultrasound-guided dry-weight reduction in hypertensive hemodialysis patients: 12-month results of a randomized controlled trial. J Hypertens. 2021 Jul 1;39(7):1444-1452. doi: 10.1097/HJH.0000000000002818.
- Pandhi P, Ter Maaten JM, Anker SD, Ng LL, Metra M, Samani NJ, Lang CC, Dickstein K, de Boer RA, van Veldhuisen DJ, Voors AA, Sama IE. Pathophysiologic Processes and Novel Biomarkers Associated With Congestion in Heart Failure. JACC Heart Fail. 2022 Sep;10(9):623-632. doi: 10.1016/j.jchf.2022.05.013.
- Kaptein MJ, Kaptein EM. Inferior Vena Cava Collapsibility Index: Clinical Validation and Application for Assessment of Relative Intravascular Volume. Adv Chronic Kidney Dis. 2021 May;28(3):218-226. doi: 10.1053/j.ackd.2021.02.003.
- Ma L, Zhao S. Risk factors for mortality in patients undergoing hemodialysis: A systematic review and meta-analysis. Int J Cardiol. 2017 Jul 1;238:151-158. doi: 10.1016/j.ijcard.2017.02.095. Epub 2017 Feb 22.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
Otros números de identificación del estudio
- 48681309
- Beca de investigación (Otro identificador: Fundación SENEFRO)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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