Comparing automated peritoneal dialysis with remote management to standard peritoneal dialysis
Comparative Study of Automated Peritoneal Dialysis With Remote Patient Management And Continuous Ambulatory Peritoneal Dialysis on the Prognosis and QOL in Peritoneal Dialysis Patients
This study is testing whether automated peritoneal dialysis with remote management can improve the health and quality of life for people with end-stage kidney disease compared to standard peritoneal dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05738525 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enroll 750 patients with end-stage renal disease to compare the prognosis and quality of life outcomes between two types of peritoneal dialysis: automated peritoneal dialysis with remote patient management (APD-RPM) and continuous ambulatory peritoneal dialysis (CAPD). Participants will be followed for a total of 156 weeks, attending follow-up visits every 12 weeks. The study will assess the effectiveness of these two treatment approaches based on real-world data and patient experiences.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of end-stage renal disease who have been on peritoneal dialysis for at least three months.
Not a fit: Patients preparing for kidney transplantation or those requiring hemodialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which dialysis method offers better outcomes for patients with end-stage renal disease.
How similar studies have performed: While there have been studies comparing different dialysis methods, the specific combination of APD-RPM and CAPD in this observational format is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Beijing, Beijing Municipality
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xiangmei Chen — Chinese PLA General Hospital
- Study coordinator: Xiangmei Chen
- Email: xmchen301@126.com
- Phone: 86-10-66935462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.