Modulation of Inflammation by Medium Cut Off Membranes (MCO-IF)

Technical University of Munich

Status: Unknown

Conditions: End Stage Renal Disease; Cardiovascular Diseases

Treatments: Device: Medium cut off dialysis; Device: Standard High Flux Dialyzer

Study type: Interventional

Funder types: Other

Identifiers

NCT03270371

MCO-CS-559/16S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

MCO Dialysis

Experimental group

Description:

Theranova Dialyzer

Treatment:

Device: Medium cut off dialysis

Standard High Flux Dialysis

Active Comparator group

Description:

Standard High Flux Dialyzer

Treatment:

Device: Standard High Flux Dialyzer