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This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of domestic APD machine compared with the patients followed CAPD.
Peritoneal dialysis (PD) is one of important way of renal replacement treatment worldwide. In China, about 40,000 patients suffered from end stage renal disease treated with PD, and almost of them followed continuous ambulatory peritoneal dialysis (CAPD) because of the expensive price of import automated PD (APD) machines although the higher clearance of solute, lower rate of PD related peritonitis and higher quality of life (QOL) in patients treated with APD compared those with CAPD. Now, cheaper domestic APD machines ( PDGO, Fuzhou, China) are accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive APD while those in control group will receive CAPD for 8 weeks. After followed-up for 8 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A APDGroup | Experimental | PDGO APD machines used in the PD patients for 8 weeks |
|
| B CAPDGroup | Active Comparator | CAPD used in the PD Patients for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APD | Other | PDGO APD machines used in the PD patients for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of dialysis | kt/v | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Residual kidney function | Residual kidney kt/v | up to 6 months |
| Peritoneal function | Peritoneal equilibration test | up to 6 months |
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Inclusion criteria:
Exclusion criteria:
(1)Stop PD for more than 10 days (2)The patient demand to quit from the RCT (3)With serious adverse events.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zongpei Jiang, M.D. & Ph.D. | Contact | 8620-38379727 | jx.home@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zongpei Jiang, M.D. & Ph.D. | The Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
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| ID | Term |
|---|---|
| D010531 | Peritoneal Dialysis, Continuous Ambulatory |
| ID | Term |
|---|---|
| D000553 | Ambulatory Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D010530 | Peritoneal Dialysis |
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| CAPD |
| Other |
CAPD used in the PD Patients for 8 weeks |
|
| D006435 |
| Renal Dialysis |
| D017582 | Renal Replacement Therapy |
| D016060 | Sorption Detoxification |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |