Combination of Hemodialysis With Hemoperfusion：A Clinical Study

Chinese PLA General Hospital (301 Hospital)

Status: Completed

Conditions: Quality of Life; Renal Dialysis; Hemoperfusion

Treatments: Device: high flux dialyzer; Device: hemoperfusion apparatus; Device: low flux dialyzer

Study type: Interventional

Funder types: Other

Identifiers

NCT02461953

2014-011

Details and patient eligibility

About

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.

Enrollment: 440 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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440 participants in 4 patient groups

low flux hemodialysis

Experimental group

Description:

low flux hemodialysis alone, 3 times a week, 4 hours per session

Treatment:

Device: low flux dialyzer

high flux hemodialysis

Experimental group

Description:

high flux hemodialysis alone, 3 times a week, 4 hours per session

Treatment:

Device: high flux dialyzer

low flux hemodialysis + hemoperfusion

Experimental group

Description:

low flux hemodialysis 2times a week and the HD+HP once a week

Treatment:

Device: hemoperfusion apparatus

Device: low flux dialyzer

high flux hemodialysis + hemoperfusion

Experimental group

Description:

high flux hemodialysis 2times a week and the HD+HP once a week

Treatment:

Device: high flux dialyzer

Device: hemoperfusion apparatus