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Peritoneal Dialysis (PD) is a Renal Replacement Therapy for patients with renal insufficiency that has been used more frequently in recent years. In PD treatment, catheter are used to provide access to the peritoneal cavity, allowing the dialysate to be introduced and removed from the abdomen. The aim of this study is to evaluate the safety and efficacy of long-term treatment with PD catheters (developed by Fresenius Medical Care (FME)) in adult and paediatric patients treated with CAPD or APD. Safety and performance parameters of the catheters will be analyzed, as well as data on PD treatment outcome, such as Peritoneal Clearance and Peritoneal Ultrafiltration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD treatment | Include all the patients treated with peritoneal dialysis (PD or APD) using the PD catheter as described and who who will begin PD, or patients who began PD within the last 1.5 years before start of the study |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety variables | Catheter related infections (e.g. peritonitis, tunnel infections, exit site infection) | Every 6 months (± 2 months, as per centre practice) |
| Safety variables | Non-infectious complications | Every 6 months (± 2 months, as per centre practice) |
| Safety variables | Biocompatibility (allergic reaction) | Every 6 months (± 2 months, as per centre practice) |
| Safety variables | Identify new emerging risks | Every 6 months (± 2 months, as per centre practice) |
| Safety variables | Monitor side effects | Every 6 months (± 2 months, as per centre practice) |
| Safety variables | Catheter removal | Every 6 months (± 2 months, as per centre practice) |
| Measure | Description | Time Frame |
|---|---|---|
| Performance variables | Catheter patency | very 6 months (± 2 months, as per centre practice) |
| Performance variables | Non-infectious complication |
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Inclusion Criteria:
Exclusion Criteria:
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All the patients treated with peritoneal dialysis (PD or APD) using the PD catheter as described and who who will begin PD, or patients who began PD within the last 1.5 years before start of the study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fiona Bellando | Contact | +49 6172 8868776 | fiona.bellando@freseniusmedicalcare.com | |
| Celina Meyer | Contact | +49 6172 268 6809 | celina.meyer@freseniusmedicalcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Fedai Özcan, Dr. med. | Klinikum Dortmund Wirbelsäulenchirurgie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Dortmund gGmbH | Dortmund | 44137 | Germany |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| very 6 months (± 2 months, as per centre practice) |
| Outcome variables | Peritoneal clearance | very 6 months (± 2 months, as per centre practice) |
| Outcome variables | Peritoneal UF | very 6 months (± 2 months, as per centre practice) |
| Outcome variables | Mechanical complications | very 6 months (± 2 months, as per centre practice) |
| Outcome variables | Therapy tolerability. | very 6 months (± 2 months, as per centre practice) |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |