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WithdrawnNCT02904343Updated Jun 26, 2018

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

An interventional study of domestic hemodialysis machine and imported hemodialysis machine in Hemodialysis, sponsored by Chinese PLA General Hospital. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-26.

Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
The sponsors want to stop the study.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hemodialysis

Keywords

  • hemodialysis machine
  • quality
  • safety
  • domestic
03

In context

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Group of domestic hemodialysis machine

    Device: domestic hemodialysis machine

  • Active comparator
    Group of imported hemodialysis machine

    Device: imported hemodialysis machine

Interventions

  • Devicedomestic hemodialysis machine

    WEGO, DBB-27C

  • Deviceimported hemodialysis machine

    Fresenius, 4008s

06

What researchers measure

Primary outcomes

  1. Adverse reactions associated with the use of dialysis machines

    Time frame: 0 to 3 months

Secondary outcomes

  1. The results of endotoxin level of dialysate

    endotoxin level of dialysis fluid at outlet

    Time frame: 0,1,2,3 months

  2. The results of bacterial culture of dialysate

    bacterial culture of dialysis fluid at outlet

    Time frame: 0,1,2,3 months

  3. Clearance rate of uremic toxins

    Time frame: 0,1,2,3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02904343
Lead sponsor
Chinese PLA General Hospital
Responsible party
Xiangmei Chen (Professor,Chief physician,Academician of Chinese Academy of Engineering, Chinese PLA General Hospital) — Principal investigator
First posted
Sep 16, 2016
Start date
Sep 2017 (estimated)
Primary completion
Oct 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Jun 26, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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