Renal Failure Acute Chronic
Conditions
Keywords
Automated peritoneal dialysis, paedriatic patients, Kt/V, ultrafiltration, Chronic Kidney Disease
Brief summary
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.
Interventions
DEVICETreatment with the pedriatic mode of the APD cycler
Patients weighing less than 20 kg will be treated for 4 weeks with APD using the PAED mode of the Silencia PD cycler
Sponsors
Fresenius Medical Care Deutschland GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Body weight ≤ 20 kg * Ability to understand the nature and requirements of the study
Exclusion criteria
* 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 * Life expectancy \< 3 months * Patients who suffer from peritonitis/exit site infection during the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total weekly Kt/V urea | The primary endpoint is total Kt/Vurea at week 2 and 4 | The primary objective is to determine whether patients achieve a total weekly Kt/V urea ≥ 1.8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean daily ultrafiltration (UF) | Mean UF will be measured at weeks 2 and 4 | — |
| Residual renal function (RRF) | RRF will be measured at weeks 2 and 4 | Renal urea clearance |
Contacts
Primary ContactTatiana De los Ríos
Outcome results
None listed