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| Name | Class |
|---|---|
| Winicker Norimed GmbH | INDUSTRY |
| James Motta, Clinical Research Associate (CRA) | UNKNOWN |
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The study has been designed in order to investigate the performance and safety of the new Silencia PD cycler including the Silencia tubing system in comparison to the PD-Night and Homechoice PD cycler which are both well-established PD cyclers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peritoneal dialysis PD | Experimental | Treatment for 2 weeks either with the comparators PD-Night or Homechoice PD cycler depending on the previous treatment (clinical phase I). At the end of these 2 treatment weeks and a subsequent training phase which up to 3 weeks, treatment with the Silencia PD cycler for 2 further weeks (clinical phase II). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD cycler Silencia | Device | Treatment for 2 weeks either with PD-Night or Homechoice PD cycler (Comparators) depending on the previous Treatment ((clinical phase I). At the end of these 2 treatment weeks and a subsequent training phase which up to 3 weeks, treatment with the Silencia PD cycler for 2 further weeks (clinical phase II). |
| Measure | Description | Time Frame |
|---|---|---|
| Total Kt/V urea | Measurement of solute removal during peritoneal dialysis focuses on urea | at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days) |
| Achieving Kt/Vurea ≥ 1.7 | Measurement of solute removal during peritoneal dialysis focuses on urea | at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days) |
| Mean daily ultrafiltration (UF) | Daily ultrafiltration reached by the Patient with APD | at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Machuca, Dr | Fresenius Medical Care Chile S.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephocare La Serena | La Serena | Chile | ||||
| Nephocare Independencia |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Prospective, controlled, multicentre, interventional
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|
| Santiago |
| Chile |
| Nephocare Providencia | Santiago | Chile |
| Nephocare San Bernardo | Santiago | Chile |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |