Comparative Study of Automated Peritoneal Dialysis With Remote Patient Management And Continuous Ambulatory Peritoneal Dialysis on the Prognosis and QOL in Peritoneal Dialysis Patients
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY
This is an observational, multicenter, parallel control study, planning to enroll 750 eligible patients to receive automated peritoneal dialysis with remote patient management (APD-RPM) and continuous ambulatory peritoneal dialysis (CAPD). Patients will attend follow-up every 12 ± 1 weeks for a total of 156 weeks. This study aims to compare the effects of APD-RPM and CAPD treatment on the prognosis and quality of life.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Aged 18 years to 75 years
• Confirmed diagnosis of end-stage renal disease
• Standard peritoneal balance test shows rapid peritoneal solute transfer rate, defined as 4 hours D/P creatinine value greater than 0.65
• Be able to comply with the standard peritoneal dialysis treatment at home
• Peritoneal dialysis time 3 months and longer
• Fully understand the study and have signed the informed consent
Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Xiangmei Chen
xmchen301@126.com
86-10-66935462
Backup
Jianhui Zhou
china_pd@126.com
86-10-66937011
Time Frame
Start Date:2023-06
Estimated Completion Date:2026-12
Participants
Target number of participants:750
Treatments
Automated peritoneal dialysis with remote patient management (APD-RPM)
APD mode is recommended but not limited to continuous circulating peritoneal dialysis (CCPD). Dialysis dose ranges from 5 to 10 liters per day and glucose concentration starts from low concentration (1.5%).
Continuous ambulatory peritoneal dialysis (CAPD)
(1) Dialysis dose ranges from 5 to 10 liters per day at the run-in period. For those with regular peritoneal dialysis, the original dose can be used according to the volume status and solute clearance effect in the past 3 months; (2) Exchange time and abdominal retention time is generally 2-5 times and 1 time at daytime and night, separately; (3) Glucose concentration includes 1.5%, 2.5% or 4.25%; (4) The treatments can be adjusted according to the change of residual renal function, peritoneal transport characteristics, volume status, solute clearance, clinical status and peritonitis.