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Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine

Primary Purpose

Kidney Failure,Chronic

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FM peritoneal dialysis machine
HOMECHOICE peritoneal dialysis machine
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure,Chronic focused on measuring Automated PD, Effectiveness, Safety, Manipulability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FM peritoneal dialysis machine

HOMECHOICE peritoneal dialysis machine

Arm Description

FM peritoneal dialysis machine APD 10L/10h;

HOMECHOICE peritoneal dialysis machine APD 10L/10h;

Outcomes

Primary Outcome Measures

Daily peritoneal Kt/V

Secondary Outcome Measures

The accuracy of filling

Full Information

First Posted
August 14, 2015
Last Updated
December 9, 2019
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02525497
Brief Title
Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine
Official Title
A Randomized, Multicenter, Crossover Study Comparing the Domestic FM Peritoneal Dialysis Machine With Baxter HOMECHOICE
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure,Chronic
Keywords
Automated PD, Effectiveness, Safety, Manipulability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FM peritoneal dialysis machine
Arm Type
Experimental
Arm Description
FM peritoneal dialysis machine APD 10L/10h;
Arm Title
HOMECHOICE peritoneal dialysis machine
Arm Type
Active Comparator
Arm Description
HOMECHOICE peritoneal dialysis machine APD 10L/10h;
Intervention Type
Device
Intervention Name(s)
FM peritoneal dialysis machine
Intervention Description
FM peritoneal dialysis machine APD 10L/10h
Intervention Type
Device
Intervention Name(s)
HOMECHOICE peritoneal dialysis machine
Intervention Description
HOMECHOICE peritoneal dialysis machine APD 10L/10h
Primary Outcome Measure Information:
Title
Daily peritoneal Kt/V
Time Frame
1 day
Secondary Outcome Measure Information:
Title
The accuracy of filling
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
The accuracy of filling temperature
Time Frame
1 day
Title
Serum sodium before and after dialysis
Time Frame
1 day
Title
Serum potassium before and after dialysis
Time Frame
1 day
Title
Serum calcium before and after dialysis
Time Frame
1 day
Title
Serum phosphorus before and after dialysis
Time Frame
1 day
Title
Serum carbon dioxide binding force before and after dialysis
Time Frame
1 day
Title
Serum creatinine before and after dialysis
Time Frame
1 day
Title
Serum urea nitrogen before and after dialysis
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHEN Xiangmei, yes
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30511680
Citation
Cao XY, He YN, Zhou JH, Sun SR, Miao LN, Chen W, Fang JA, Wang M, Wang NS, Lin HL, Liu J, Ni ZH, Liu WH, Na Y, Zhao JY, Guo ZY, Zheng HG, Shi W, Jiang GR, Cai GY, Chen XM. Safety, Effectiveness, and Manipulability of Peritoneal Dialysis Machines Made in China: A Randomized, Crossover, Multicenter Clinical Study. Chin Med J (Engl). 2018 Dec 5;131(23):2785-2791. doi: 10.4103/0366-6999.246079.
Results Reference
derived

Learn more about this trial

Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine

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