comparative study of prognosis and qol between apd-rpm and capd

Conditions: End-stage Renal Disease

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.

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.

Eligibility 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

Keywords: apd-rpm capd prognosis qol comparative study