Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Location status: Recruiting
NCT Number: NCT05738525
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Beijing, Beijing Municipality, 100853, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 156 weeks from baseline
The time from baseline to all-cause death or technical failure
Time frame: 156 weeks from baseline
Change of quality of life (QOL) score from the baseline
Time frame: 156 weeks from baseline
Change of assessment of returning to society from the baseline
Time frame: Up to 156 weeks
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
Change of ultrafiltration rate from baseline
Time frame: Up to 156 weeks
Degree, proportion and frequency of capacity overload
Time frame: Up to 156 weeks
Proportion of well-controlled hypertension. Quantity of antihypertension drugs
Time frame: 156 weeks from baseline
Proportion of peritonitis. Time to first peritonitis from enrollment
Time frame: Up to 156 weeks
Change of slope of renal function Glomerular Filtration Rate (GFR)
Time frame: 24, 48, 72, 96 120, 144, 156 week
Change of subjective global assessment (SGA) score from baseline
Time frame: Up to 156 weeks
Proportion of adequacy of dialysis
Time frame: Up to 156 weeks
Times of prescription adjustment, outpatient follow-up and unplanned outpatient visits
Time frame: Up to 156 weeks
Proportion of hospitalization and unplanned hospitalization
Contact information is provided by the study sponsor or research team.
Jianhui Zhou
CONTACT
Xiangmei Chen
CONTACT
Chinese PLA General Hospital
Other
Comparative Study of Automated Peritoneal Dialysis With Remote Patient Management And Continuous Ambulatory Peritoneal Dialysis on the Prognosis and QOL in Peritoneal Dialysis Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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