NCT07721636

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Jul 2026Feb 2027

Study Start

First participant enrolled

July 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 12, 2026

Last Update Submit

July 18, 2026

Conditions

Keywords

dry weightPOCUSHemodialysisVExUS

Outcome Measures

Primary Outcomes (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

    3 months

Study Arms (1)

Patients on maintenance hemodialysis

OTHER

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

Interventions

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

Also known as: POCUS, VEXUS, lung US
Patients on maintenance hemodialysis

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University Hospitals

Alexandria, Egypt

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of internal medicine

Study Record Dates

First Submitted

July 12, 2026

First Posted

July 23, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

patients did not consent for sharing their data

Locations