Usefulness of the VExUS Protocol for Dry-Weight Adjustment in Hemodialysis Patients: The Multicenter VExHD Study (VEX-HD)

June 19, 2026 updated by: Patrica De Sequera, Fundación Senefro

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28055
        • Hospital Universitario Infanta Leonor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: congestive
Patients who have increased ultrafiltration
Behavioral: Increased ultrafiltration
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.
Active Comparator: Non-congested
Patients in whom ultrafiltration was not increased
Behavioral: No increase in ultrafiltration
In patients who do not meet the predefined ultrasonographic criteria for venous congestion, the ultrafiltration prescription will remain unchanged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Dry weight
Time Frame: 4 weeks
To evaluate the usefulness of the VExUS protocol in dry-weight adjustment in hemodialysis patients.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in systolic blood pressure
Time Frame: 4 weeks
Change in systolic and diastolic blood pressure associated with ultrafiltration practices during the study period.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Senefro

Collaborators

SOMANE (MADRID SOCIETY OF NEPHROLOGY)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48681309
  • Beca de investigación (Other Identifier: Fundación SENEFRO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be analyzed at this center and has also been anonymized using a code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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