Actively Recruiting
Comparative Study of Automated Peritoneal Dialysis With Remote Patient Management And Continuous Ambulatory Peritoneal Dialysis on the Prognosis and QOL in Peritoneal Dialysis Patients
Led by Chinese PLA General Hospital · Updated on 2023-06-22
750
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two types of peritoneal dialysis treatments—automated peritoneal dialysis with remote patient management (APD-RPM) and continuous ambulatory peritoneal dialysis (CAPD)—in patients with end-stage renal disease. This observational, multicenter study plans to enroll 750 adult patients aged 18 to 75 years who have been on peritoneal dialysis for at least three months and who have a rapid peritoneal solute transfer rate. The study aims to assess the effects of these treatments on patients' prognosis and quality of life over a period of 156 weeks. Participants will be divided into two groups, with about 250 receiving APD-RPM and 500 receiving CAPD. APD-RPM involves a recommended mode of continuous circulating peritoneal dialysis with a dialysis dose ranging from 5 to 10 liters per day and glucose concentrations starting from a low level. Remote monitoring tracks treatment details and alerts. The CAPD group receives a dialysis dose of 5 to 10 liters per day during the run-in period, with exchanges occurring 2 to 5 times during the day and once at night. Glucose concentrations in CAPD vary from 1.5% to 4.25%, and treatments can be adjusted based on individual patient factors. Patients will attend follow-up visits approximately every 12 weeks for up to 156 weeks. Researchers will monitor outcomes including all-cause deaths, technical failure, quality of life, return to society, cardio-cerebrovascular events, ultrafiltration rate, hypertension, peritonitis, nutritional status, dialysis adequacy, hospitalizations, and treatment adjustments. The study collects detailed clinical and laboratory data to understand long-term effects and safety of the two dialysis methods.
CONDITIONS
Brief Title
Comparative Study of Prognosis and QOL Between APD-RPM and CAPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Prepare for kidney transplantation within 3 years
- Need combined treatment of hemodialysis
- Be allergic to components of peritoneal dialysis fluid
- Complicated with severe cardio-cerebrovascular diseases such as congestive heart failure, grade III and above of NYHA classification, acute myocardial infarction within 3 months, malignant arrhythmia requiring treatment, dilated cardiomyopathy, acute cerebral infarction or acute cerebral hemorrhage within 3 months, etc.
- Complicated with serious liver diseases, such as cirrhosis or acute liver injury [Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) 2 times greater the the normal]
- Active or treated residual malignant tumors, HIV infection
- Pregnant or lactating women at childbearing age who disagree to use effective contraceptives during the trial
- History of alcohol or drug (illegal drugs) abuse
- Unable to continue CAPD due to ultrafiltration failure
- Mental retardation or mental illness
- Patients who use icodextrin dialysate
- Participation in other clinical trials in the past 3 months
- Peritonitis in the past 3 months
- Other situations decided by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 156 weeks
Participants undergo either automated peritoneal dialysis with remote patient management (APD-RPM) or continuous ambulatory peritoneal dialysis (CAPD) as part of their standard care. Dialysis doses and glucose concentrations are adjusted based on individual treatment needs and clinical status.
Ongoing outpatient follow-up visits as part of routine care
Duration - Up to 156 weeks
Participants are observed for outcomes including quality of life, dialysis adequacy, and complications such as peritonitis and cardio-cerebrovascular events over the study period.
Scheduled outpatient visits with assessments at multiple time points including weeks 24, 48, 72, 96, 120, 144, and 156
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
X
Xiangmei Chen
J
Jianhui Zhou
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here