Medium-term Modulation of the Inflammatory Profile by Medium-cut Off Membranes in Patients With End Stage Renal Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Technical University of Munich
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in inflammation
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in inflammation
Time Frame: 240 days (cross-over design, multiple measurements)
change of inflammatory score (inflammatory score is derived from multiple biomarkers)
Secondary Outcomes
- change in calcification propensity(240 days (cross-over design, multiple measurements))
- Change in calcification status(240 days (cross-over design, multiple measurements))