End Stage Renal Disease, Inflammation
Conditions
Keywords
inflammation, dialysis
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.
Interventions
DEVICEHCO1100
Dialysis
DEVICEP210H
Dialysis
Sponsors
Gambro Dialysatoren GmbH
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of CD162 expression on monocytes | 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
| Measure | Time frame | Description |
|---|---|---|
| Albumin blood level | 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase) | change of albumin blood level, 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) |
Countries
Germany
Outcome results
None listed