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

Chinese PLA General Hospital (301 Hospital)

Status: Withdrawn

Conditions: Hemodialysis

Treatments: Device: domestic hemodialysis machine; Device: imported hemodialysis machine

Study type: Interventional

Funder types: Other

Identifiers

NCT02904343

S2015-046-01

Details and patient eligibility

About

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.

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. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Group of domestic hemodialysis machine

Experimental group

Treatment:

Device: domestic hemodialysis machine

Group of imported hemodialysis machine

Active Comparator group

Treatment:

Device: imported hemodialysis machine