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| Name | Class |
|---|---|
| Alcedis GmbH | INDUSTRY |
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This clinical study evaluates the performance of the MultifiltratePro in pediatric mode for Continuous Venovenous Hemodiafiltration (CVVHD) in children. Its primary aim is to assess the efficacy of the MultifiltratePro in paediatric mode, specifically in achieving at least 80% of the prescribed effluent dose within 72 hours. Additionally, the study focuses on the safety of this mode in a paediatric setting, closely monitoring for clinical adverse events, hemodynamic instability, and electrolyte imbalances. Paediatric patients with body weights between 8kg and 40kg will be treated with the MultifiltratePro for a period of up to 10 days, with the treatment duration and approach being tailored to the severity of each patient's condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVVHD treatment in paediatric mode with multiFiltratePRO | Experimental | Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVVHD treatment in paediatric mode with multiFiltratePRO | Device | Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO |
| Measure | Description | Time Frame |
|---|---|---|
| Effluent dose | Performance parameters of the paediatric treatment mode of multiFiltratePRO based on the effluent dose (prescribed vs achieved effluent dose) at 72 hours (at least 80% of the machine prescribed dose) are analysed | 0 hours and 72 hours after start of treatment |
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Inclusion criteria:
General:
Study-specific:
Exclusion criteria:
General:
Study-specific:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuela Stauss-Grabo, Dr. | Contact | +4961726085248 | manuela.stauss-grabo1@freseniusmedicalcare.com | |
| Lena Wachter | Contact | +49 6172 2686464 | lena.wachter@freseniusmedicalcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Merker, Dr. med. | Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Frankfurt | Frankfurt | 60590 | Germany |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |