Status:
UNKNOWN
Hemodiafiltration With Endogenous Reinfusion on Uremic Toxins Clearance of Maintenance Hemodialysis Patients
Lead Sponsor:
RenJi Hospital
Conditions:
To Evaluate the Clearance Rate of Uremic Toxin by HFR
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
1.1Primary Objective To evaluate the clearance rate of uremic toxin β2-microglobulin (β2-MG), indoxyl sulfate and λ-free light chain (λFLC) by HFR. 1.2Secondary Objectives 1.1.1 To evaluate the clear...
Eligibility Criteria
Inclusion
- 18-75 years old, regardless of gender.
- MHD for at least 3 months, and blood purification treatment for 3 times per week.
- The vascular access is autogenous arteriovenous fistula or artificial blood vessels，with a blood flow ≥200mL/min.
- spKt/V≥1.2.
- Patients who signed the informed consent form (ICF) voluntarily.
Exclusion
- Patients who have participated in other interventional clinical trials within a month.
- Pregnant or lactating women.
- Patients of NYHA class IV or occurred acute coronary syndrome or myocardial infarction in 3 months before the start of the study.
- Patients with active hemorrhage in 2 weeks (e.g., cerebral hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage, etc.).
- Patients with unstable blood pressure (pre-dialysis systolic blood pressure ≥180 or ≤90mmHg, pre-dialysis diastolic blood pressure ≥100 or ≤60mmHg), severe anemia (hemoglobin ≤60g/L), and high risk of blood coagulation (e.g., albumin ≤25g/L or hemoglobin ≥140g/L).
- Patients with severe infection (the level of hypersensitive C-reactive protein(hsCRP) ≥ 10×upper limit of normal).
- Patients with a history of drug addiction or severe mental disorders.
- Other conditions in which the investigators reject patients to participate in this study.
Key Trial Info
Start Date :
August 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06002529
Start Date
August 18 2023
End Date
July 1 2025
Last Update
August 21 2023
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