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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-11-10-002741 | Other Identifier | Eudamed |
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| Name | Class |
|---|---|
| Gambro Dialysatoren GmbH | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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Chronic dialysis patients with end stage renal disease have an increased mortality rate as compared to the age matched healthy population. It is known that chronic inflammation contributes to the high incidence of cardiovascular events in chronic dialysis patients. Dialyzers made by membranes with increased pore size (high cut-off Dialyzer HCO1100) may be beneficial in the elimination of inflammatory mediators and may improve the inflammatory status. Hypothesis: In this study it will be investigated whether the treatment with HCO1100 will improve the inflammatory status of chronic dialysis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCO1100-P14L | Experimental | HCO1100 is connected in row with low flux dialyzer P14L |
|
| P210H | Active Comparator | High flux Filter P210H |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCO1100 | Device | Dialysis |
| |
| P210H |
| Measure | Description | Time Frame |
|---|---|---|
| change of CD162 expression on monocytes | change of CD162 expression on monocytes, timepoints in each treatment phase: 1.)1st.day (prae dialysis) 2.)1st.day (post dialysis) 3.)2nd.day (prae dialysis) 4.)8th.day (prae dialysis) 5.)15th.day (prae dialysis) 6.)22nd.day (prae dialysis) | 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase) |
| Measure | Description | Time Frame |
|---|---|---|
| Albumin blood level | change of albumin blood level, timepoints in each treatment phase: 1.)1st.day (prae dialysis) 2.)1st.day (post dialysis) 3.)2nd.day (prae dialysis) 4.)8th.day (prae dialysis) 5.)15th.day (prae dialysis) 6.)22nd.day (prae dialysis) | 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Girndt, MD | Martin-Luther-Universität Halle-Wittenberg | Study Director |
| Ralf Schindler, MD | Charité, Humboldt Universität Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KfH Bachstzelzenweg 4 | Halle | Saxony-Anhalt | 06120 | Germany | ||
| KfH-Bismarkstrasse 95-96 |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Device |
Dialysis |
|
| Berlin |
| 10625 |
| Germany |
| D052776 |
| Female Urogenital Diseases |
| 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 |