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| Name | Class |
|---|---|
| Fresenius Medical Care Deutschland GmbH | INDUSTRY |
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Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type.
Study objectives: Intraindividual comparison of removal rate of urea, phosphate, ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during post-dilution online hemodiafiltration.
Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea, phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dialyser | Active Comparator | FX CorDiax 60 dialyzer |
|
| FXDialyser | Active Comparator | FX 60 dialyzer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dialyzer comparison | Other | Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type (FX CorDiax 60or FX 60 ) The order of dialyzers used will be randomly assigned to the patient at the time of randomisation by lot. Every subject will be treated one time with each dialyzer. In order to achieve controlled conditions, the mid- or end-week session data will be used, only. |
| Measure | Description | Time Frame |
|---|---|---|
| Removal rate of myoglobin | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Removal rate of urea | 2 weeks | |
| Removal rate of phosphate | 2 weeks | |
| Removal rate of ß2-microglobulin (ß2-m) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic | Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24662288 | Result | Maduell F, Arias-Guillen M, Fontsere N, Ojeda R, Rico N, Vera M, Elena M, Bedini JL, Wieneke P, Campistol JM. Elimination of large uremic toxins by a dialyzer specifically designed for high-volume convective therapies. Blood Purif. 2014;37(2):125-30. doi: 10.1159/000358214. Epub 2014 Mar 20. |
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| ID | Term |
|---|---|
| D007688 | Kidneys, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Dialyzer | Device | Comparison Dialyzer FX60 versus Cordiax60 |
|
| 2 weeks |
| Removal rate of prolactin | 2 weeeks |
| Removal rate of alpha1-microglobulin | 2 weeks |
| Removal rate of alpha1-acid glycoprotein | 2 weeks |
| Hematocrit pre and post-dialysis | 2 weeks |
| Albumin loss during dialysis session | 2 weeks |