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Hemodialysis PatientNCT07721636

VEXUS and Assessment of Dry Weight of Patients on Hemodialysis

A study testing ULTRASOUND for volume assessment in people with Hemodialysis Patient and Dry Weight, run by Alexandria University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Hemodialysis Patient, Dry Weight
What is being tested?
ULTRASOUND for volume assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Jul 2026to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting
  • Alexandria University Hospitals

    Alexandria

    Sara Taha Ibrahim, Assistant professor, 00201150654036, sarataha_86@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read more

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.
Read the detailed description

All study participants will undergo a comprehensive array of assessments

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

  1. 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.
  1. 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
  2. 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.

Being tested
ULTRASOUND for volume assessment
Keywords
dry weight, POCUS, Hemodialysis, VExUS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ULTRASOUND for volume assessmentDiagnostic test

    Also called POCUS, VEXUS, lung US

    usage of US to determine patient dry weight and ultrafiltration volume needed

Study groups in NCT07721636
Study groupRoleWhat they receive
Patients on maintenance hemodialysisOtherthe same patients will be used as their own control in two phase study where US will be used to determine patients dry weight
Receives: Diagnostic Test: ULTRASOUND for volume assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2026
  2. Study start1 Jul 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07721636
Sponsor's protocol ID
0109628
Status last verified
Jul 2026
First submitted
12 Jul 2026
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: patients did not consent for sharing their data

Questions about this trial

What is this clinical trial studying?

A study testing ULTRASOUND for volume assessment in people with Hemodialysis Patient and Dry Weight, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of patients dry weight between the two phases of the study (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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