Validity and Security of Domestic Automated Peritoneal Dialysis Machine: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Disorders Associated With Peritoneal Dialysis
- Sponsor
- Sun Yat-sen University
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Adequacy of dialysis
- Last Updated
- 11 years ago
Overview
Brief Summary
This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of domestic APD machine compared with the patients followed CAPD.
Detailed Description
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.
Investigators
Yanhong Deng
Sun Yat-sen University
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Adequacy of dialysis
Time Frame: up to 8 weeks
kt/v
Secondary Outcomes
- Residual kidney function(up to 6 months)
- Peritoneal function(up to 6 months)