Hemoperfusion, Quality of Life, Renal Dialysis
Conditions
Keywords
hemodialysis, hemoperfusion, quality of life
Brief summary
This study is a prospective, randomized, controlled multicenter clinical study. The aim of the study is to investigate whether the combination of maintenance hemodialysis (MHD) with hemoperfusion (HP) could improve the clearance rate of middle and large molecule uremic toxins so as to improve the quality of life of MHD patients and reduce their mortality rate.
Interventions
DEVICEhemoperfusion apparatus
DEVICElow flux dialyzer
DEVICEhigh flux dialyzer
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18, male or female 2. Maintenance hemodialysis duration\>3 months 3. Regular hemodialysis,3 times a week,4 hours per session 4. Vascular access unlimited 5. iPTH≥300pg/ml 6. Sign the written informed consent
Exclusion criteria
1. Allergic to dialysis equipment 2. PLT\<60×10\^9/L 3. Blood flow\<200ml/min 4. Serum albumin\<30g/L 5. Kt/V\<1.2 6. iPTH\>800pg/ml 7. Hemodiafiltration 8. Coagulation disorder, severe bleeding tendency, with active bleeding 9. Severe hypotension, severe cardiopulmonary insufficiency 10. Under other drug trial 11. Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance rate of uremic toxins | 0,3,6,12 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of quality of life | 0,3,6,12 months |
Countries
China
Outcome results
None listed