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

NCT06981559 | Not Yet Recruiting DMC

• 1 other identifier: KY2024-1356
• Study Type: observational
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (3)

• Number of participants with MCI as assessed by Montreal Cognitive Assessmen

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

  month 12 and month 36

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

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

  month 12 and month 36

• Number of participants with Sarcopenia as assessed by using BIA

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

  month 12 and month 36

Secondary Outcomes (9)

• Toxin removal efficiency

  month 12 and month 36

• Solute removal efficiency

  month 12 and month 36

• Toxin removal efficiency

  month 12 and month 36

• Toxin removal efficiency

  month 12 and month 36

• Solute removal efficiency

  month 12 and month 36

Study Arms (1)

high-frequency hemoperfusion group

≥1 session every 2 weeks

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be divided into two groups based on the frequency of hemoperfusion treatments they receive: the high-frequency hemoperfusion group (≥1 session every 2 weeks) and the low-frequency hemoperfusion group (\<1 session every 2 weeks).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• xujiao chen: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 20, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 20, 2025

Record last verified: 2025-04