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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high-frequency hemoperfusion group | ≥1 session every 2 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Toxin removal efficiency | Decline rate of β2-MG from baseline level | month 12 and month 36 |
| Solute removal efficiency | spKt/V | month 12 and month 36 |
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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.
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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).
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| Toxin removal efficiency | Decline rate of IL-6 from baseline level | month 12 and month 36 |
| Toxin removal efficiency | Decline rate of proteomics and metabolomics from baseline levels | month 12 and month 36 |
| Solute removal efficiency | URR | month 12 and month 36 |
| Solute removal efficiency | electrolytes (potassium) | month 12 and month 36 |
| Solute removal efficiency | electrolytes (sodium) | month 12 and month 36 |
| Solute removal efficiency | electrolytes (calcium) | month 12 and month 36 |
| Solute removal efficiency | electrolytes (phosphorus) | month 12 and month 36 |