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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SilenciaPAED | Experimental | Patients will receive treatment as prescribed by the physician using the Silencia PD cycler. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with the pedriatic mode of the APD cycler | Device | Patients weighing less than 20 kg will be treated for 4 weeks with APD using the PAED mode of the Silencia PD cycler |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total weekly Kt/V urea | The primary objective is to determine whether patients achieve a total weekly Kt/V urea ≥ 1.8. | The primary endpoint is total Kt/Vurea at week 2 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean daily ultrafiltration (UF) | Mean UF will be measured at weeks 2 and 4 | |
| Residual renal function (RRF) | Renal urea clearance | RRF will be measured at weeks 2 and 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tatiana De los RÃos | Contact | +4961726092688876 | tatiana.de-los-rios@freseniusmedicalcare.com |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Residual renal function (RRF) | Renal creatinine clearance | RRF will be measured at weeks 2 and 4 |
| Residual renal function (RRF) | 24h urine output | RRF will be measured at weeks 2 and 4 |
| Residual renal function (RRF) | GFR (calculated during the analysis) | RRF will be measured at weeks 2 and 4 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |