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.
This is an observational study based on the real-word diagnosis and treatments. Target subject population include end-stage renal disease patients (aged 18-75 years) with peritoneal dialysis 3 months and longer. Standard peritoneal balance test of eligible patients should be rapid peritoneal solute transfer rate (4-hour D/P creatinine value \> 0.65). Patients will be divided into two groups to receive standard APD-RPM or CAPD with a ratio of 1:2. Peritoneal dialysis in APD-RPM group (n=250): (1) APD mode is recommended but not limited to continuous circulating peritoneal dialysis (CCPD); (2) Dialysis dose ranges from 5 to 10 liters per day and depends on previous APD prescription and dialysis adequacy; (3) Glucose concentration starts from low concentration (1.5%) and depends on previous dialysis prescription. Peritoneal dialysis in CAPD group (n=500): (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.
Study Type
OBSERVATIONAL
Enrollment
750
APD mode is recommended but not limited to continuous circulating peritoneal dialysis (CCPD); (2) Dialysis dose ranges from 5 to 10 liters per day and depends on previous APD prescription and dialysis adequacy; (3) Glucose concentration starts from low concentration (1.5%) and depends on previous dialysis prescription. Remote monitoring includes dynamic changes of the overall treatment situation, warning or any abnormal notes, and drainage, retention and duration of APD per day.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGComposite endpoint of all-cause deaths/technical failure
The time from baseline to all-cause death or technical failure
Time frame: 156 weeks from baseline
Quality of life (QOL)
Change of quality of life (QOL) score from the baseline
Time frame: 156 weeks from baseline
Returning to society
Change of assessment of returning to society from the baseline
Time frame: 156 weeks from baseline
Cardio-cerebrovascular events
Incidence of cardio-cerebrovascular events, including sudden cardiac death, serious arrhythmia, coronary heart disease requiring interventional treatment, congestive heart failure with grade III and above of New York Heart Association (NYHA) classification, acute cerebral infarction, and acute cerebral hemorrhage
Time frame: Up to 156 weeks
Ultrafiltration rate
Change of ultrafiltration rate from baseline
Time frame: Up to 156 weeks
Capacity overload
Degree, proportion and frequency of capacity overload
Time frame: Up to 156 weeks
Hypertension and antihypertension drugs
Proportion of well-controlled hypertension. Quantity of antihypertension drugs
Time frame: Up to 156 weeks
Peritonitis
Proportion of peritonitis. Time to first peritonitis from enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 156 weeks from baseline
Glomerular Filtration Rate
Change of slope of renal function Glomerular Filtration Rate (GFR)
Time frame: Up to 156 weeks
Nutritional status
Change of subjective global assessment (SGA) score from baseline
Time frame: 24, 48, 72, 96 120, 144, 156 week
Adequacy of dialysis
Proportion of adequacy of dialysis
Time frame: Up to 156 weeks
Prescription adjustment, outpatient follow-up and unplanned outpatient visits
Times of prescription adjustment, outpatient follow-up and unplanned outpatient visits
Time frame: Up to 156 weeks
Hospitalization
Proportion of hospitalization and unplanned hospitalization
Time frame: Up to 156 weeks