Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine
This trial is active, not recruiting.
|Treatments||fm peritoneal dialysis machine, homechoice peritoneal dialysis machine|
|Sponsor||Chinese PLA General Hospital|
|Start date||July 2015|
|End date||October 2016|
|Trial size||300 participants|
|Trial identifier||NCT02525497, MD-PD-2014|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
Daily peritoneal Kt/V
time frame: 1 day
The accuracy of filling
time frame: 1 day
Male or female participants at least 18 years old.
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
|Official title||A Randomized, Multicenter, Crossover Study Comparing the Domestic FM Peritoneal Dialysis Machine With Baxter HOMECHOICE|
|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.|
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