The Silencia PD (peritoneal dialysis) cycler offers a pediatric (PAED) mode with advanced features such as Time and Volume Optimization (TAVO), supporting precise and individualized treatment. This study evaluates the efficacy and tolerability of Automated Peritoneal Dialysis (APD) using the Silencia PD cycler in patients weighing ≤ 20 kg and able to tolerate a minimum inflow volume of 100 mL. The primary objective is to determine whether patients achieve a total weekly Kt/Vurea ≥ 1.8.
Informed consent signed and dated by legal representative and investigator/authorized physician
The minors have received the information referred to in Article 63(2) MDR in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children
The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator
patients with renal failure treated or planned to be treated with APD
Any conditions which could interfere with the patient's ability to comply with the study
Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
Participation in an interventional clinical study during the preceding 30 days
Previous participation in the same study
Single group
Treatment with the pedriatic mode of the APD cycler
DevicePatients weighing less than 20 kg will be treated for 4 weeks with APD using the PAED mode of the Silencia PD cycler
Total weekly Kt/V urea
The primary objective is to determine whether patients achieve a total weekly Kt/V urea ≥ 1.8.
Mean daily ultrafiltration (UF)
Residual renal function (RRF)
Renal urea clearance
Residual renal function (RRF)
Renal creatinine clearance
Residual renal function (RRF)
24h urine output
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
