Permeability Enhancement to Reduce Chronic Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-07-31

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.

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Detailed Description

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Conditions

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End Stage Renal Disease Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HCO1100-P14L

HCO1100 is connected in row with low flux dialyzer P14L

Group Type EXPERIMENTAL

HCO1100

Intervention Type DEVICE

Dialysis

P210H

High flux Filter P210H

Group Type ACTIVE_COMPARATOR

P210H

Intervention Type DEVICE

Dialysis

Interventions

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HCO1100

Dialysis

Intervention Type DEVICE

P210H

Dialysis

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No