Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine
December 9, 2019 updated by: Chen Xiangmei, Chinese PLA General Hospital
A Randomized, Multicenter, Crossover Study Comparing the Domestic FM Peritoneal Dialysis Machine With Baxter HOMECHOICE
This study is a randomized, multi-center，crossover study of a domestic FM peritoneal dialysis machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Our study is a randomized, multi-center，crossover study.
It compares a domestic FM peritoneal dialysis machine with Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.
Study Type
Interventional
Enrollment (Actual)
360
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Chinese PLA General Hospital
-
-
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:
Age ≥18, male or female Dialysis duration:≥30 days Sign the written informed consent
Exclusion Criteria:
Hemodialysis Exit site infection or tunnel infection Peritonitis ≤30 days before screening Catheter mechanical failure Anti-HIV positive Allergic to components of dialysate Comorbidity:Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure,hypertension Poor compliance Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial Has a history of alcoholism and drug abuse (defined as illegal drugs) Any circumstances when patients are believed unsuitable for this trial
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: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FM peritoneal dialysis machine
FM peritoneal dialysis machine APD 10L/10h;
|
FM peritoneal dialysis machine APD 10L/10h
|
|
Active Comparator: HOMECHOICE peritoneal dialysis machine
HOMECHOICE peritoneal dialysis machine APD 10L/10h;
|
HOMECHOICE peritoneal dialysis machine APD 10L/10h
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Daily peritoneal Kt/V
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The accuracy of filling
Time Frame: 1 day
|
1 day
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The accuracy of filling temperature
Time Frame: 1 day
|
1 day
|
|
Serum sodium before and after dialysis
Time Frame: 1 day
|
1 day
|
|
Serum potassium before and after dialysis
Time Frame: 1 day
|
1 day
|
|
Serum calcium before and after dialysis
Time Frame: 1 day
|
1 day
|
|
Serum phosphorus before and after dialysis
Time Frame: 1 day
|
1 day
|
|
Serum carbon dioxide binding force before and after dialysis
Time Frame: 1 day
|
1 day
|
|
Serum creatinine before and after dialysis
Time Frame: 1 day
|
1 day
|
|
Serum urea nitrogen before and after dialysis
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
July 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
August 14, 2015
First Submitted That Met QC Criteria
August 14, 2015
First Posted (Estimate)
August 17, 2015
Study Record Updates
Last Update Posted (Actual)
December 11, 2019
Last Update Submitted That Met QC Criteria
December 9, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD-PD-2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.