Permeability Enhancement to Reduce Chronic Inflammation

Study Overview
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Brief Summary
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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.

Official Title
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Permeability Enhancement to Reduce Chronic Inflammation

Conditions
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End Stage Renal Disease, Inflammation

Intervention / Treatment
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* Device: HCO1100
* Device: P210H


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCO1100-P14L<br>HCO1100 is connected in row with low flux dialyzer P14L | Device: HCO1100<br>* Dialysis<br>|
| Active Comparator: P210H<br>High flux Filter P210H | Device: P210H<br>* Dialysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of CD162 expression on monocytes | 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) | 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Albumin blood level | 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) | 8 weeks (3 weeks treatment phase, 2 weeks wash out phase, 3 weeks treatment phase) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammation, dialysis