VEXUS and Assessment of Dry Weight of Patients on Hemodialysis

Contribution of Lung Ultrasound and VExUS Score in Assessment of Volume Status in Maintenance Hemodialysis Patients.

This is a prospective, single-arm study that will be conducted over a period of 24 weeks. The same maintenance HD patients will be followed sequentially in two study phases, with each patient serving as their own control.

The study aims to evaluate the role of POCUS, including LUS and VExUS score, in improving the assessment of volume status and determination of dry weight in patients undergoing maintenance HD.

Phase I (Weeks 1-12): Clinical Assessment Phase During the first 12 weeks, all patients will be managed using standard clinical assessment alone. Determination of dry weight and calculation of target ultrafiltration (UF) will rely primarily on clinical parameters, including physical examination and routine clinical judgment.

Phase II (Weeks 13-24): POCUS-guided assessment period During the second 12 weeks, the same patients will undergo POCUS assessment, including LUS and VExUS Score.

LUS and VExUS examinations will be performed 30 minutes after the scheduled hemodialysis session. All measurements will be conducted during the mid-week dialysis session to reflect the average hydration status of each patient.

At the end of each phase, the results of all patients will be correlated with assessment of dry weight by BIS (Inbody version 720).

Inclusion criteria:

ESRD patients on maintenance HD for more than three months. In the HD unit at Medical Research Institute and Faculty of Medicine. Alexandria University.

Age: 25 -65 years old. The ability to give informed consent.

Exclusion criteria:

• Patients with previous echocardiographic evidence of right heart dysfunction, tricuspid valve disease, or IVC thrombosis.
• Patients with liver cirrhosis
• Lung diseases: interstitial lung diseases, COPD patients.
• Obese (BMI≥30) Before inclusion in the study, all patients will be required to fill out a written informed consent. Also, approval from the Medical Ethics Committee will be obtained. Maintenance hemodialysis patients.

Study Overview

• Status: Recruiting
• Conditions: Dry Weight; Hemodialysis Patient
• Intervention / Treatment: Diagnostic test: ULTRASOUND for volume assessment

Detailed Description

All study participants will undergo a comprehensive array of assessments

Before the midweek session, which will include the following evaluations:

I. Full history taking and clinical assessment A thorough evaluation will include patient age, gender, cause of ESRD, duration of dialysis, and detailed cardiac and pulmonary medical history, including any intradialytic hypotension or hypertension episodes.

At the end of each mid-week session, blood pressure, pulse oximetry measurement, and respiratory symptoms will be assessed in the 2 phases of the study.

II. Laboratory Investigations:

A comprehensive panel of tests will be conducted, including

• Complete blood count (CBC).
• Blood urea (Pre and post-dialysis for Kt/V calculation), serum creatinine and serum albumin.

III. Assessment of dialysis adequacy:

By measurement of Kt/V.

IV. Echocardiography Will be done for all patients in the study V. Ultrafiltration Prescription and Volume Assessment Clinical Determination of Target Ultrafiltration During the clinical assessment phase, target UF will be prescribed based on standard clinical parameters. These include interdialytic weight gain, pre- and post-dialysis body weight, blood pressure trends (any intradialytic hypotension or hypertension episodes), presence of peripheral edema, chest auscultation, pulmonary symptoms, and jugular venous pressure in cmH2O where assessable, and intradialytic symptoms such as hypotension or muscle cramps.

Estimated dry weight will be determined clinically, and target UF will be calculated as the difference between pre-dialysis weight and estimated dry weight. The ultrafiltration rate will be recorded in millilitres per minute per kilogram of body weight.

During the POCUS-guided phase:

LUS Eight-zone examination:

• LUS will be used to assess pulmonary congestion by quantifying B-lines as a marker of extravascular lung water. The presence of multiple B-lines will indicate pulmonary congestion and support adjustment of dry weight and target UF. Conversely, minimal or absent B-lines will suggest euvolemia, prompting avoidance of unnecessary UF escalation to reduce the risk of intradialytic hypotension.

• In this study, each hemithorax is divided into four areas (two anterior, two lateral). For a scan to be considered abnormal, it must meet the following criteria:

  • multiple artefacts per scan (at least three)
  • positive findings in more than one scan per side
  • positive findings bilaterally.

VExUS Score:

• Venous congestion will be evaluated using ultrasound and Doppler-based techniques 30 minutes after the HD session during the POCUS-guided phase.

• The assessment will include:

  1. Measurement of the static diameter of the inferior vena cava (IVC).

     • Normal: IVC less than 20 mm
     • Abnormal: IVC is greater than or equal to 20 mm.

  2. Recording of hepatic venous (HV) flow, classified as follows:

     Normal: Continuous systolic flow greater than diastolic flow Abnormal: Systolic flow less than diastolic flow Severely Abnormal: Systolic flow reversal

  3. Assessment of portal vein (PV) pulsatility using pulsed-wave Doppler. PV patterns include:

     Normal: Continuous flow Abnormal: Pulsatile flow If pulsatile flow is detected, the pulsatility index (PI) will be calculated to assess the severity of the abnormality.

     The PI is determined using the formula: (PVmax -PVmin)/PVmax × 100).

• Measurements will be categorised based on Doppler findings and used to determine the VExUS score (0-3).

Note: The intrarenal flow profile will be omitted from the VExUS score due to its frequent unreliability and inconsistent detectability in previous studies Involving dialysis patients.

- Higher VExUS grades will indicate significant systemic venous congestion and support modification of dry weight and/or increase in target UF, provided hemodynamic stability is maintained. Lower VExUS grades will indicate minimal venous congestion and guide conservative UF strategies when clinically appropriate.

Bio-impedance spectroscopy:

At the end of each phase, all patients' volume status will be assessed by using a Biospace InBody 720 body composition analyzer to be correlated with the results of each phase.

InIntegrated Volume Assessment and Safety Considerations Target UF prescription during the POCUS-guided phase will be based on an integrated assessment combining clinical evaluation, LUS, and VExUS findings. Adjustments to UF and dry weight will be performed gradually and individualised for each patient, with careful attention to patient tolerance and intradialytic hemodynamic stability. Excessive UF rates and intradialytic complications will be actively avoided.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria University Hospitals
    • Contact: Sara Taha Ibrahim, Assistant professor; Phone Number: 00201150654036; Email: sarataha_86@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ESRD patients on maintenance HD for more than three months.
• In the HD unit at the Medical Research Institute and Faculty of Medicine. Alexandria University.
• Age: 25 -65 years old.
• The ability to give informed consent.

Exclusion Criteria:

• Patients with previous echocardiographic evidence of right heart dysfunction, tricuspid valve disease, or IVC thrombosis.
• Patients with liver cirrhosis
• Lung diseases: interstitial lung diseases, COPD patients.
• Obese (BMI≥30)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients on maintenance hemodialysis; the same patients will be used as their own control in two phase study where US will be used to determine patients dry weight	Diagnostic test: ULTRASOUND for volume assessment; usage of US to determine patient dry weight and ultrafiltration volume needed; Other Names: POCUS; VEXUS; lung US

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of patients dry weight between the two phases of the study	Change of patient dry weight (in KG ) measured by bioimpedance device between the two phases of the study	3 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: July 12, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Hemodialysis; dry weight; POCUS; VExUS
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: 0109628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: patients did not consent for sharing their data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No