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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02904343
Other study ID # S2015-046-01
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2017
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

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2017
Est. primary completion date October 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. 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
domestic hemodialysis machine
WEGO, DBB-27C
imported hemodialysis machine
Fresenius, 4008s

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse reactions associated with the use of dialysis machines 0 to 3 months
Secondary The results of endotoxin level of dialysate endotoxin level of dialysis fluid at outlet 0,1,2,3 months
Secondary The results of bacterial culture of dialysate bacterial culture of dialysis fluid at outlet 0,1,2,3 months
Secondary Clearance rate of uremic toxins 0,1,2,3 months
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