Clinical trial NCT06981559: A Clinical Study on the Impact of Hemoperfusion on the Prognosis of Uremic Patients Undergoing Maintenance Hemodialysis
Official title: A Clinical Study on the Impact of Hemoperfusion on the Prognosis of Uremic Patients Undergoing Maintenance Hemodialysis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemodialysis
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with MCI as assessed by Montreal Cognitive Assessmen
timeFrame: month 12 and month 36
measure: Number of participants with cardiovascular events according to ACC/AHA guideline
timeFrame: month 12 and month 36
measure: Number of participants with Sarcopenia as assessed by using BIA
timeFrame: month 12 and month 36
Secondary outcomes:
measure: Toxin removal efficiency
timeFrame: month 12 and month 36
measure: Solute removal efficiency
timeFrame: month 12 and month 36
measure: Toxin removal efficiency
timeFrame: month 12 and month 36
measure: Toxin removal efficiency
timeFrame: month 12 and month 36
measure: Solute removal efficiency
timeFrame: month 12 and month 36
measure: Solute removal efficiency
timeFrame: month 12 and month 36
measure: Solute removal efficiency
timeFrame: month 12 and month 36
measure: Solute removal efficiency
timeFrame: month 12 and month 36
measure: Solute removal efficiency
timeFrame: month 12 and month 36
Other outcomes:
Locations:
Study officials:
References: