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

Hemodialysis Clinical Trial

Official title:

Evaluation of Domestic Hemodialysis Machine (WEGO DBB-27C) : A Multi-center Clinical Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02904343
• Other study ID #: S2015-046-01
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Hemodialysis

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