Efficacy and Tolerability of the APD Treatment in PAED Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment with the pedriatic mode of the APD cycler.
- Who it may be relevant to
- Registry conditions: Renal Failure Acute Chronic. Basic parameters: from 0 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Tolerability of the APD Treatment of Toddlers and Newborns With the Silencia PD Cycler
Overview
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
- Device Treatment 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
Primary outcome measures
- Total weekly Kt/V urea [Time frame: The primary endpoint is total Kt/Vurea at week 2 and 4]
Secondary outcome measures (5)
- Mean daily ultrafiltration (UF) [Time frame: Mean UF will be measured at weeks 2 and 4]
- Residual renal function (RRF) [Time frame: RRF will be measured at weeks 2 and 4]
- Residual renal function (RRF) [Time frame: RRF will be measured at weeks 2 and 4]
- Residual renal function (RRF) [Time frame: RRF will be measured at weeks 2 and 4]
- Residual renal function (RRF) [Time frame: RRF will be measured at weeks 2 and 4]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07004907 · PD-Silencia-02-LA