Cardiovascular Diseases, End Stage Renal Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMedium cut off dialysis
Hemodialysis
DEVICEStandard High Flux Dialyzer
Hemodialysis
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* time since initiation of dialysis \> 3 months * age \> 18 years
Exclusion criteria
* time since initiation of dialysis \< 3 months * age \< 18 years * ongoing acute or chronic infection/malignoma, because this will interfere with inflammatory baseline values * major surgery less than 2 weeks before inclusion in the study * pregnancy * mental illness * lack of written and informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammation | 240 days (cross-over design, multiple measurements) | change of inflammatory score (inflammatory score is derived from multiple biomarkers) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in calcification status | 240 days (cross-over design, multiple measurements) | calcification score derived from several pro- and anticalcifying biomarkers |
| change in calcification propensity | 240 days (cross-over design, multiple measurements) | this values measures the resistence of serum to a calcification stimulus |
Countries
Germany
Contacts
Primary ContactChristoph Schmaderer, MD
Backup ContactGeorg Lorenz, MD
Outcome results
None listed