Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-30

Study Completion Date

2017-12-31

Brief Summary

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An important reason for the costs of hemodialysis treatment in China are expensive is the hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is the basis equipment of the hemodialysis treatment. After years of research and development, China has had the domestic hemodialysis machine. However, due to the lack of control studies of domestic and imported hemodialysis machine, thus causing the domestic hemodialysis machine promotion has been hindered. The aim of this study is to verify the quality and safety of domestic hemodialysis machine.

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Detailed Description

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Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group of domestic hemodialysis machine

Group Type EXPERIMENTAL

domestic hemodialysis machine

Intervention Type DEVICE

WEGO, DBB-27C

Group of imported hemodialysis machine

Group Type ACTIVE_COMPARATOR

imported hemodialysis machine

Intervention Type DEVICE

Fresenius, 4008s

Interventions

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domestic hemodialysis machine

WEGO, DBB-27C

Intervention Type DEVICE

imported hemodialysis machine

Fresenius, 4008s

Intervention Type DEVICE

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. Sign the written informed consent

Exclusion Criteria

1. Acute kidney injury
2. Prepare to transfer to kidney transplantation or peritoneal dialysis in a year.
3. Positive in Hepatitis B virus, hepatitis C virus, syphilis or HIV
4. Pregnancy or lactation
5. Under other drug trial
6. Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor
7. Can not be treated in accordance with the research program

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No