Combination of Hemodialysis With Hemoperfusion：A Clinical Study

Study Overview
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Brief Summary
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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.

Official Title
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HA130 Hemoperfusion Apparatus Combined Hemodialysis to Improve Quality of Life in Patients Undergoing Maintenance Hemodialysis：A Perspective, Randomized, Controlled Multicenter Clinical Study

Conditions
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Renal Dialysis, Hemoperfusion, Quality of Life

Intervention / Treatment
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* Device: hemoperfusion apparatus
* Device: low flux dialyzer
* Device: high flux dialyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18, male or female Maintenance hemodialysis duration>3 months Regular hemodialysis,3 times a week,4 hours per session Vascular access unlimited iPTH≥300pg/ml Sign the written informed consent Exclusion Criteria: Allergic to dialysis equipment PLT<60×10^9/L Blood flow<200ml/min Serum albumin<30g/L Kt/V<1.2 iPTH>800pg/ml Hemodiafiltration Coagulation disorder, severe bleeding tendency, with active bleeding Severe hypotension, severe cardiopulmonary insufficiency Under other drug trial Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low flux hemodialysis<br>low flux hemodialysis alone, 3 times a week, 4 hours per session | Device: low flux dialyzer<br> <br> |
| Experimental: high flux hemodialysis<br>high flux hemodialysis alone, 3 times a week, 4 hours per session | Device: high flux dialyzer<br> <br> |
| Experimental: low flux hemodialysis + hemoperfusion<br>low flux hemodialysis 2times a week and the HD+HP once a week | Device: hemoperfusion apparatus<br> <br> * Other names: hemoperfusion apparatus(HA-130;Jafron Biomedical Co., Ltd）;Device: low flux dialyzer<br> <br> |
| Experimental: high flux hemodialysis + hemoperfusion<br>high flux hemodialysis 2times a week and the HD+HP once a week | Device: hemoperfusion apparatus<br> <br> * Other names: hemoperfusion apparatus(HA-130;Jafron Biomedical Co., Ltd）;Device: high flux dialyzer<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance rate of uremic toxins |  | 0,3,6,12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of quality of life |  | 0,3,6,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, hemodialysis, hemoperfusion