Clinical trial NCT02525497: 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
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure,Chronic
Keywords: Automated PD
Effectiveness
Safety
Manipulability
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Daily peritoneal Kt/V
timeFrame: 1 day
Secondary outcomes:
measure: The accuracy of filling
timeFrame: 1 day
Other outcomes:
measure: The accuracy of filling temperature
timeFrame: 1 day
measure: Serum sodium before and after dialysis
timeFrame: 1 day
measure: Serum potassium before and after dialysis
timeFrame: 1 day
measure: Serum calcium before and after dialysis
timeFrame: 1 day
measure: Serum phosphorus before and after dialysis
timeFrame: 1 day
measure: Serum carbon dioxide binding force before and after dialysis
timeFrame: 1 day
measure: Serum creatinine before and after dialysis
timeFrame: 1 day
measure: Serum urea nitrogen before and after dialysis
timeFrame: 1 day
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: CHEN Xiangmei, yes
role: STUDY_DIRECTOR
References:
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.