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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FM peritoneal dialysis machine | Experimental | FM peritoneal dialysis machine APD 10L/10h; |
|
| HOMECHOICE peritoneal dialysis machine | Active Comparator | HOMECHOICE peritoneal dialysis machine APD 10L/10h; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FM peritoneal dialysis machine | Device | FM peritoneal dialysis machine APD 10L/10h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily peritoneal Kt/V | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy of filling | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy of filling temperature | 1 day | |
| Serum sodium before and after dialysis | 1 day | |
| Serum potassium before and after dialysis |
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
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| Name | Affiliation | Role |
|---|---|---|
| CHEN Xiangmei, yes | Chinese PLA General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30511680 | Derived | 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. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| HOMECHOICE peritoneal dialysis machine | Device | HOMECHOICE peritoneal dialysis machine APD 10L/10h |
|
| 1 day |
| Serum calcium before and after dialysis | 1 day |
| Serum phosphorus before and after dialysis | 1 day |
| Serum carbon dioxide binding force before and after dialysis | 1 day |
| Serum creatinine before and after dialysis | 1 day |
| Serum urea nitrogen before and after dialysis | 1 day |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |