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| Name | Class |
|---|---|
| Gambro Dialysatoren GmbH | INDUSTRY |
| KfH Kuratorium für Dialyse und Nierentransplantation e.V., Neu Isenburg, Germany | UNKNOWN |
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The purpose of this study is to test whether a dialyzer with a higher than usual permeability for proteins can eliminate proinflammatory proteins from the blood of patients on regular maintenance hemodialysis who have chronically elevated levels of inflammation markers such as C-reactive protein (CRP) in their blood.
Patients with ESRD on chronic hemodialysis patients frequently have elevated markers of inflammation (e.g. serum CRP values). Hemodialysis may clear the blood from low molecular weight toxins and retention products such as creatinine, potassium, or urea. The dialyzer clearance of middle to high molecular weight substances such as cytokines and cytokine receptors is low. Nearly 50% of chronic dialysis patients have persistent subclinical inflammation which is strongly associated with cardiovascular disease and mortality. The study tests the hypothesis that removal of proteins in the weight range of 10.000-30.000 D via a more permeable dialyzer membrane reduces chronic inflammation in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCO dialyzer | Experimental | Hemodialysis with the HCO1100 hemodialyzer membrane with high molecular weight cut off. |
|
| Placebo | Active Comparator | Regular dialysis using a polyamide high-flux hemodialyzer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCO1100 dialyzer | Device | Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation: CRP plasma level and quantity of circulating CD14/16 positive monocytes | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum albumin losses | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine II, Martin-Luther-University Medical School | Halle | Saxony-Anhalt | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22845695 | Derived | Fiedler R, Neugebauer F, Ulrich C, Wienke A, Gromann C, Storr M, Bohler T, Seibert E, Girndt M. Randomized controlled pilot study of 2 weeks' treatment with high cutoff membrane for hemodialysis patients with elevated C-reactive protein. Artif Organs. 2012 Oct;36(10):886-93. doi: 10.1111/j.1525-1594.2012.01479.x. Epub 2012 Jul 30. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| regular dialysis polyamide | Device | Continuation of the regular hemodialysis using polyamide high-flux hemodialysers |
|
|
| 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 |