A Clinical Study on the Impact of Hemoperfusion on the Prognosis of Uremic Patients Undergoing Maintenance Hemodialysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hemodialysis. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Number of participants with MCI as assessed by Montreal Cognitive Assessmen [Time frame: month 12 and month 36]
- Number of participants with cardiovascular events according to ACC/AHA guideline [Time frame: month 12 and month 36]
- Number of participants with Sarcopenia as assessed by using BIA [Time frame: month 12 and month 36]
Secondary outcome measures (9)
- Toxin removal efficiency [Time frame: month 12 and month 36]
- Solute removal efficiency [Time frame: month 12 and month 36]
- Toxin removal efficiency [Time frame: month 12 and month 36]
- Toxin removal efficiency [Time frame: month 12 and month 36]
- Solute removal efficiency [Time frame: month 12 and month 36]
- Solute removal efficiency [Time frame: month 12 and month 36]
- Solute removal efficiency [Time frame: month 12 and month 36]
- Solute removal efficiency [Time frame: month 12 and month 36]
- Solute removal efficiency [Time frame: month 12 and month 36]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06981559 · KY2024-1356