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NCT Number: NCT07144332

This Study is to Estimate the Efficacy of Hemodialysis Alone for Uric Acid Clearance in Patients on Hemodialysis. In Order to Evaluate the Need of Adjuvant Uric Acid Lowering Therapy

Background: Uricemia dramatically rises with the stage of chronic kidney disease (CKD) and correlates with its mortality. Hemodialysis (HD) being the most used treatment at the end stage kidney disease in Sohag governorate , we sought to evaluate its efficacy on the clearance of uric acid (UAc) when used alone and twice per week.

Methods: A cross-sectional study of all consenting patients with CKD stage 5 recruited at random during hemodialysis sessions at hemodialysis unit in Sohag university hospital from July to December 2025. We collected socio-demographic data, relevant clinical information, hemodialysis related variables, and measured serum uric acid (SUA) levels before and after the dialysis to assess the uric acid clearance. A clearance between 65 and 80% and above 80% was considered as low and good efficacy of hemodialysis respectively

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag university faculty of medicine

Sohag, Egypt

Location status: Recruiting

Location contact

Magdy M Amin, Professor

CONTACT

About this study

Aim of the the work The aim of this study is to estimate the efficacy of Hemodialysis alone for uric acid clearance in patients on hemodialysis. In order to evaluate the need of adjuvant uric acid lowering therapy

Patients And Methods

  • Type of The study:

Prospective cross-sectional study.

  • Place of the study:

Sohag University Hospital, department of Internal Medicine and hemodialysis unit.

  • Ethical aspect:

Informed Written consent will be taken from all patients to include their data in the study, the research will be approved by medical ethics committee of Faculty of Medicine, Sohag university

Patients:

Inclusion criteria

  • We included all consenting adults aged 18 or older, on maintenance hemodialysis for at least 3 consecutive months receiving 2 to 3 sessions weekly.

Exclusion criteria

  • Patients aged < 18 years old .
  • Patients on recent hemodialysis less than 3 months.
  • We excluded patients who were on Uric acid lowering therapy (UALT).
  • Patients received less than 4 hours of hemodialysis and those who had emergency dialysis.

Number of Patients:

The study will include 100 hemodialysis patients for duration of 6 months.

  • Methods We carried out a prospective cross-sectional study at the Hemodialysis unit in Sohag University Hospital . Patients included in the study dialyzed with the Fresenius® 4008S generator (Fresenius Medical Care, St. Wendel, Germany) dialyzers , with a polysulfone synthetic dialysis membrane and bicarbonate dialysate.

The size of the dialysis membrane was estimated according to the total body surface of the patient . Membranes sizes FX60 were used for a body surface of approximately (1.2-1.5 m2 ) ; whereas FX80 between (1.6 and 1.8m2 ) and FX100 were used for body surfaces above 1.8m2.

Dialysis adequacy was calculated from the formula Kt/ V urea; K being the clearance of urea given by the dialyzer, t the duration of the dialysis session (4 h) and V the distribution volume of urea [10].

Uric acid clearance (UAc) was estimated using the formula: UAc=100 x (SUA levels before HD-SUA levels after HD) / SUA levels before HD] [14]. We defined two thresholds values for UAc (65 and 80%).

A Hemodialysis session was considered to be of low efficacy if below 65% of reduction, moderate efficacy between 65 and 80% and a good efficacy above 80% of UAc . [15].

These predictors will be included:

  • Gender.
  • Age.
  • Underlying nephropathy.
  • Average time on renal replacement therapy.
  • Comorbidities,
  • Residual renal function (< 100 ml/24 or ≥ 100 ml/24 h) of participants.
  • Current hemodialysis session parameters such as vascular access.
  • Duration of the session.
  • Time interval between the current and previous dialysis session.
  • Body mass index (BMI).
  • Blood pressure at the beginning and at the end of dialysis
  • Dialysis adequacy.
  • Blood flow (< 300ml/min or>300ml/min).
  • Serum uric acid level which were assessed on a peripheral blood sample collected 5 min before and after dialysis.

Statistical analysis

  • All collected data will be analyzed and correlated.
  • All the statistical analysis will be done by using Statistical Package for Social Sciences (SPSS Inc., Chicago, IL) version20.
  • Baseline data and patient characteristics will be presented using descriptive statistics, for example, number, percentage, mean and standard deviation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • We included all consenting adults aged 18 or older, on maintenance hemodialysis for at least 3 consecutive months receiving 2 to 3 sessions weekly

Exclusion criteria

  • Patients aged < 18 years old .
  • Patients on recent hemodialysis less than 3 months.
  • We excluded patients who were on Uric acid lowering therapy (UALT).
  • Patients received less than 4 hours of hemodialysis and those who had emergency dialysis.

Treatment and study plan

Primary outcomes

  1. study of serum uric acid level in hemodialysis patients

    Time frame: during hemodialysis session 2 to 3 hours

    milligrams per deciliter (mg/dL)

Study contacts

Contact information is provided by the study sponsor or research team.

Ali taha, Professor

CONTACT

00201005871047

Reham Hussien, master

CONTACT

[email protected]

00201092162739

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Assessment of the Efficacy of Hemodialysis on Uric Acid Clearance at End Stage Kidney Disease in Sohag University Hospital

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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