Hemodialysis
Conditions
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.
Interventions
None listed
Sponsors
xujiao chen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with MCI as assessed by Montreal Cognitive Assessmen | 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） |
| Number of participants with cardiovascular events according to ACC/AHA guideline | month 12 and month 36 | Number of participants with cardiovascular events including myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death |
| Number of participants with Sarcopenia as assessed by using BIA | 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
| Measure | Time frame | Description |
|---|---|---|
| Toxin removal efficiency | month 12 and month 36 | Decline rate of β2-MG from baseline level |
| Solute removal efficiency | month 12 and month 36 | spKt/V |
Outcome results
None listed