Permeability Enhancement to Reduce Chronic Inflammation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End Stage Renal Disease
- Sponsor
- Vantive Health LLC
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- change of CD162 expression on monocytes
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Chronic dialysis patients with end stage renal disease have an increased mortality rate as compared to the age matched healthy population. It is known that chronic inflammation contributes to the high incidence of cardiovascular events in chronic dialysis patients. Dialyzers made by membranes with increased pore size (high cut-off Dialyzer HCO1100) may be beneficial in the elimination of inflammatory mediators and may improve the inflammatory status. Hypothesis: In this study it will be investigated whether the treatment with HCO1100 will improve the inflammatory status of chronic dialysis patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Dialysis treatment for ≥ 3 months
- •Dialysis 3x weekly
- •Vascular access by fistula or CVC providing QB of ≥ 250 ml/min
- •Dialysis with high-flux dialyzer for a minimum of 2 weeks before begin of study
- •CRP \> 5mg/L at least once within 12 weeks before inclusion
- •Age \> 18 and \< 99 Years
- •Ability to give written informed consent
Exclusion Criteria
- •Missing informed consent form
- •Clinically manifested infection or current CRP-value \> 50mg/L
- •Serum albumin \< 35g/L
- •Intake of immune suppressive medication
- •Pregnancy or lactation
- •Participation in a different study
Outcomes
Primary Outcomes
change of CD162 expression on monocytes
Time Frame: 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase)
change of CD162 expression on monocytes, timepoints in each treatment phase: 1.)1st.day (prae dialysis) 2.)1st.day (post dialysis) 3.)2nd.day (prae dialysis) 4.)8th.day (prae dialysis) 5.)15th.day (prae dialysis) 6.)22nd.day (prae dialysis)
Secondary Outcomes
- Albumin blood level(8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase))