Comparative Study of Prognosis and QOL Between APD-RPM and CAPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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End-stage Renal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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%).

APD-RPM

Intervention Type DEVICE

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.

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.

No interventions assigned to this group

Interventions

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APD-RPM

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No