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NCT Number: NCT06981559

A Clinical Study on the Impact of Hemoperfusion on the Prognosis of Uremic Patients Undergoing Maintenance Hemodialysis

The goal of this real-world clinical trial study is to evaluate the impact of hemoperfusion on the prognosis of patients with End-Stage Renal Disease (ESRD) undergoing maintenance hemodialysis.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

The investigators are planning to conduct a real-world clinical trial study, enrolling patients with maintenance hemodialysis (MHD) from Huashan Hospital. Patients will be divided into two groups based on their hemoperfusion (HP) treatment frequency: high-frequency HP treatment group (≥1 session every 2 weeks) and low-frequency HP treatment group (<1 session every 2 weeks). The investigators will collect baseline demographic data, cardiovascular events, cognitive function status, and nutrition-related clinical indicators for both groups. After a 3-year follow-up, The investigators will reassess these parameters to explore the impact of HP on the prognosis of MHD patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients undergoing maintenance hemodialysis for ≥3 months Aged ≥18 years and <85 years; Regular hemodialysis treatment, 3 times per week No residual renal function (urine output <200 mL/d); Written informed consent has been obtained from the participant.

Exclusion criteria

Patients with severe cerebrovascular diseases (new-onset cerebral infarction, cerebral hemorrhage) or neurological diseases (autoimmune encephalitis, epilepsy, neurodevelopmental disorders).

Patients with acute severe infections (such as sepsis), severe cardiopulmonary insufficiency (NYHA class IV heart failure, acute exacerbation of COPD), or malignancies.

Patients receiving combined hemodialysis and peritoneal dialysis treatment. Patients with allergic reactions, contraindications, or intolerance to dialysis membrane materials.

Patients with a platelet count <60 × 10^9/L. Other conditions deemed by the investigators as unsuitable for participation in this study.

Treatment and study plan

Primary outcomes

  1. Number of participants with MCI as assessed by Montreal Cognitive Assessmen

    Time frame: month 12 and month 36

    Montreal Cognitive Assessment: A score of 24 or higher is considered normal, while a score below 24 may indicate mild cognitive impairment(MCI)

  2. Number of participants with cardiovascular events according to ACC/AHA guideline

    Time frame: month 12 and month 36

    Number of participants with cardiovascular events including myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death

  3. Number of participants with Sarcopenia as assessed by using BIA

    Time frame: month 12 and month 36

    ASMI (kg/m2) will be calculated as ASM(kg)/height 2(m2). ASM will be measured using bioimpedance analysis (BIA)

Secondary outcomes

  1. Toxin removal efficiency

    Time frame: month 12 and month 36

    Decline rate of β2-MG from baseline level

  2. Solute removal efficiency

    Time frame: month 12 and month 36

    spKt/V

  3. Toxin removal efficiency

    Time frame: month 12 and month 36

    Decline rate of IL-6 from baseline level

  4. Toxin removal efficiency

    Time frame: month 12 and month 36

    Decline rate of proteomics and metabolomics from baseline levels

  5. Solute removal efficiency

    Time frame: month 12 and month 36

    URR

  6. Solute removal efficiency

    Time frame: month 12 and month 36

    electrolytes (potassium)

  7. Solute removal efficiency

    Time frame: month 12 and month 36

    electrolytes (sodium)

  8. Solute removal efficiency

    Time frame: month 12 and month 36

    electrolytes (calcium)

  9. Solute removal efficiency

    Time frame: month 12 and month 36

    electrolytes (phosphorus)

Sponsors and collaborators

Lead sponsor

xujiao chen

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 20, 2025
Registry last updated
May 20, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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