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

  • China
    • 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;
Device: FM peritoneal dialysis machine
FM peritoneal dialysis machine APD 10L/10h
Active Comparator: HOMECHOICE peritoneal dialysis machine
HOMECHOICE peritoneal dialysis machine APD 10L/10h;
Device: HOMECHOICE peritoneal dialysis machine
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

Chinese PLA General Hospital

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.

General Publications

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.

Clinical Trials on Kidney Failure,Chronic

Clinical Trials on FM peritoneal dialysis machine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe