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NCT02461953 Clinical Trial

Combination of Hemodialysis With Hemoperfusion：A Clinical Study

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02461953
Other study ID # 2014-011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date December 2017

Study information
Verified date June 2018
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 440
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• hemoperfusion apparatus

• low flux dialyzer

• high flux dialyzer

Locations
Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clearance rate of uremic toxins 0,3,6,12 months
Secondary Evaluation of quality of life 0,3,6,12 months
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