Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine

Not Applicable

Completed

• Conditions: Kidney Failure,Chronic
• Interventions: Device: FM peritoneal dialysis machine; Device: HOMECHOICE peritoneal dialysis machine

• Registration Number: NCT02525497
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-17
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FM peritoneal dialysis machine	FM peritoneal dialysis machine	FM peritoneal dialysis machine APD 10L/10h;
HOMECHOICE peritoneal dialysis machine	HOMECHOICE peritoneal dialysis machine	HOMECHOICE peritoneal dialysis machine APD 10L/10h;

Primary Outcome Measures

Name	Time	Method
Daily peritoneal Kt/V	1 day

Secondary Outcome Measures

Name	Time	Method
The accuracy of filling	1 day

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China