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

June 22, 2018 updated by: Xiangmei Chen, Chinese PLA General Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group of domestic hemodialysis machine
Device: domestic hemodialysis machine
WEGO, DBB-27C
ACTIVE_COMPARATOR: Group of imported hemodialysis machine
Device: imported hemodialysis machine
Fresenius, 4008s

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse reactions associated with the use of dialysis machines
Time Frame: 0 to 3 months
0 to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The results of endotoxin level of dialysate
Time Frame: 0,1,2,3 months
endotoxin level of dialysis fluid at outlet
0,1,2,3 months
The results of bacterial culture of dialysate
Time Frame: 0,1,2,3 months
bacterial culture of dialysis fluid at outlet
0,1,2,3 months
Clearance rate of uremic toxins
Time Frame: 0,1,2,3 months
0,1,2,3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2017

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (ESTIMATE)

September 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 22, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S2015-046-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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