Combination of Hemodialysis With Hemoperfusion:A Clinical Study

NCT ID: NCT02461953

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-12-31

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.

Detailed Description

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Conditions

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Renal Dialysis Hemoperfusion Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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low flux hemodialysis

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

Group Type EXPERIMENTAL

low flux dialyzer

Intervention Type DEVICE

high flux hemodialysis

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

Group Type EXPERIMENTAL

high flux dialyzer

Intervention Type DEVICE

low flux hemodialysis + hemoperfusion

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

Group Type EXPERIMENTAL

hemoperfusion apparatus

Intervention Type DEVICE

low flux dialyzer

Intervention Type DEVICE

high flux hemodialysis + hemoperfusion

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

Group Type EXPERIMENTAL

hemoperfusion apparatus

Intervention Type DEVICE

high flux dialyzer

Intervention Type DEVICE

Interventions

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hemoperfusion apparatus

Intervention Type DEVICE

low flux dialyzer

Intervention Type DEVICE

high flux dialyzer

Intervention Type DEVICE

Other Intervention Names

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hemoperfusion apparatus(HA-130;Jafron Biomedical Co., Ltd)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiangmei Chen

Professor,Chief physician,Academician of Chinese Academy of Engineering,Chinese PLA General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2014-011

Identifier Type: -

Identifier Source: org_study_id

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