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This study examines whether medium-cut off dialysis results in improved blood purification of large middle molecules e.g. inflammatory molecules compared to hemodialysis (HD) treatments with conventional high-flux dialyzers.
Cardiovascular events and sepsis remain the leading causes of mortality in patients on maintenance hemodialysis. Thus expectancy of life for these patients is comparable to the prognosis of metastasized cancer. So far the exact mechanisms causing excess mortality in hemodialysis patients remain elusive, but chronic inflammation seems to play a central role in the pathogenesis of cardiovascular disease in HD patients.
Keeping this in mind the Theranova medium-cut off membrane, with its ability to clear middle molecules (0,5-50 kDa), seems suitable to further improve clearance of inflammatory mediators as the non-protein bound inflammatory mediators lie within the cut off range of this membrane. The investigators designed this study to get information on the changes in the inflammatory milieu in dialysis patients when using medium-cut off membranes which are know to significantly reduce cytokines compared to standard high-flux dialyzers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCO Dialysis | Experimental | Theranova Dialyzer |
|
| Standard High Flux Dialysis | Active Comparator | Standard High Flux Dialyzer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medium cut off dialysis | Device | Hemodialysis |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammation | change of inflammatory score (inflammatory score is derived from multiple biomarkers) | 240 days (cross-over design, multiple measurements) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in calcification status | calcification score derived from several pro- and anticalcifying biomarkers | 240 days (cross-over design, multiple measurements) |
| change in calcification propensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph Schmaderer, MD | Contact | 0049894140 | 5053 | christoph.schmaderer@mri.tum.de |
| Georg Lorenz, MD | Contact | 0049894140 | 6704 | georg.lorenz@mri.tum.de |
| Name | Affiliation | Role |
|---|---|---|
| Christoph Schmaderer, MD | attending Department of Nephrology, Klinikum rechts der Isar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of nephrology, Klinikum rechts der Isar | Recruiting | München | Bavaria | 81675 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28535525 | Background | Ronco C, La Manna G. Expanded Hemodialysis: A New Therapy for a New Class of Membranes. Contrib Nephrol. 2017;190:124-133. doi: 10.1159/000468959. Epub 2017 May 23. | |
| 28085888 | Background | Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Medium cut off Dialyzer compared with standard of care High-Flux Dialyzer (Fx Cor Diax 60®). No others changes in our standard of care maintenance dialysis is planned, dialysis specific parameters such as blood flow will be kept unchanged during the study period).
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no masking
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| Standard High Flux Dialyzer | Device | Hemodialysis |
|
this values measures the resistence of serum to a calcification stimulus
| 240 days (cross-over design, multiple measurements) |
| 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 |