End-stage Renal Disease
Conditions
Keywords
APD-RPM, CAPD, Prognosis, QOL, Comparative Study
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAPD-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.
Sponsors
Chinese PLA General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of all-cause deaths/technical failure | 156 weeks from baseline | The time from baseline to all-cause death or technical failure |
| Quality of life (QOL) | 156 weeks from baseline | Change of quality of life (QOL) score from the baseline |
| Returning to society | 156 weeks from baseline | Change of assessment of returning to society from the baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypertension and antihypertension drugs | Up to 156 weeks | Proportion of well-controlled hypertension. Quantity of antihypertension drugs |
| Peritonitis | 156 weeks from baseline | Proportion of peritonitis. Time to first peritonitis from enrollment |
| Glomerular Filtration Rate | Up to 156 weeks | Change of slope of renal function Glomerular Filtration Rate (GFR) |
| Cardio-cerebrovascular events | 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 |
| Adequacy of dialysis | Up to 156 weeks | Proportion of adequacy of dialysis |
| Prescription adjustment, outpatient follow-up and unplanned outpatient visits | Up to 156 weeks | Times of prescription adjustment, outpatient follow-up and unplanned outpatient visits |
| Hospitalization | Up to 156 weeks | Proportion of hospitalization and unplanned hospitalization |
| Nutritional status | 24, 48, 72, 96 120, 144, 156 week | Change of subjective global assessment (SGA) score from baseline |
| Ultrafiltration rate | Up to 156 weeks | Change of ultrafiltration rate from baseline |
| Capacity overload | Up to 156 weeks | Degree, proportion and frequency of capacity overload |
Countries
China
Contacts
Primary ContactXiangmei Chen
Backup ContactJianhui Zhou
Outcome results
None listed