Validity and Security of Domestic Automated Peritoneal Dialysis Machine: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
APD
+ CAPD
Treatment Study
Summary
Study start date: January 1, 2015
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.600 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion criteria: 1. The duration of PD is more than 1 month. 2. The age is range from 18 to 80 years old. 3. The patient can be treated with regular PD in home. 4. The volume of peritoneal dialysate is from 8L to 10 L in 1 day. 5. The patient can be visited regularly. 6. The patient must be freely given informed consent Exclusion criteria: 1. Peritonitis was happened within 1 month 2. The KT/V\<1.7 3. Infections in the exit or tunnel 4. With tumors. 5. With low transport of peritoneum. 6. With mental and behavior disorders. 7. With acute renal failure 8. Hemodialysis meanwhile 9. With heart failure( NYHA III-IV ) or cardio- cerebrovascular events 10. Attending other clinical trails 11. Refused to give informed consent Exit criteria （1）Stop PD for more than 10 days （2）The patient demand to quit from the RCT （3）With serious adverse events.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Guangzhou, ChinaOpen Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University in Google Maps