Combination of Hemodialysis With Hemoperfusion：A Clinical Study

Not Applicable

Completed

• Conditions: Quality of Life; Hemoperfusion; Renal Dialysis
• Interventions: Device: hemoperfusion apparatus; Device: high flux dialyzer; Device: low flux dialyzer

• Registration Number: NCT02461953
• Lead Sponsor: Chinese PLA General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-03
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-22
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
high flux hemodialysis + hemoperfusion	hemoperfusion apparatus	high flux hemodialysis 2times a week and the HD+HP once a week
high flux hemodialysis	high flux dialyzer	high flux hemodialysis alone, 3 times a week, 4 hours per session
low flux hemodialysis + hemoperfusion	low flux dialyzer	low flux hemodialysis 2times a week and the HD+HP once a week
high flux hemodialysis + hemoperfusion	high flux dialyzer	high flux hemodialysis 2times a week and the HD+HP once a week
low flux hemodialysis	low flux dialyzer	low flux hemodialysis alone, 3 times a week, 4 hours per session
low flux hemodialysis + hemoperfusion	hemoperfusion apparatus	low flux hemodialysis 2times a week and the HD+HP once a week

Primary Outcome Measures

Name	Time	Method
Clearance rate of uremic toxins	0,3,6,12 months

Secondary Outcome Measures

Name	Time	Method
Evaluation of quality of life	0,3,6,12 months

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China