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Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine

NCT ID: NCT02525497

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Kidney Failure,Chronic

Keywords

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Automated PD Effectiveness Safety Manipulability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FM peritoneal dialysis machine

FM peritoneal dialysis machine APD 10L/10h;

Group Type EXPERIMENTAL

FM peritoneal dialysis machine

Intervention Type DEVICE

FM peritoneal dialysis machine APD 10L/10h

HOMECHOICE peritoneal dialysis machine

HOMECHOICE peritoneal dialysis machine APD 10L/10h;

Group Type ACTIVE_COMPARATOR

HOMECHOICE peritoneal dialysis machine

Intervention Type DEVICE

HOMECHOICE peritoneal dialysis machine APD 10L/10h

Interventions

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FM peritoneal dialysis machine

FM peritoneal dialysis machine APD 10L/10h

Intervention Type DEVICE

HOMECHOICE peritoneal dialysis machine

HOMECHOICE peritoneal dialysis machine APD 10L/10h

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen Xiangmei

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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CHEN Xiangmei, yes

Role: STUDY_DIRECTOR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 30511680 (View on PubMed)

Other Identifiers

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MD-PD-2014

Identifier Type: -

Identifier Source: org_study_id