Modulation of Inflammation by Medium Cut Off Membranes

Not Applicable

• Conditions: Cardiovascular Diseases; End Stage Renal Disease
• Interventions: Device: Medium cut off dialysis; Device: Standard High Flux Dialyzer

• Registration Number: NCT03270371
• Lead Sponsor: Technical University of Munich

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-29
• Last Update Submitted: 2017-08-29
• Study Start: 2017-09-01
• Study First Posted: 2017-09-01
• Last Update Posted: 2017-09-01
• Primary Completion: 2018-10
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MCO Dialysis	Medium cut off dialysis	Theranova Dialyzer
Standard High Flux Dialysis	Standard High Flux Dialyzer	Standard High Flux Dialyzer

Primary Outcome Measures

Name	Time	Method
Change in inflammation	240 days (cross-over design, multiple measurements)	change of inflammatory score (inflammatory score is derived from multiple biomarkers)

Secondary Outcome Measures

Name	Time	Method
change in calcification propensity	240 days (cross-over design, multiple measurements)	this values measures the resistence of serum to a calcification stimulus
Change in calcification status	240 days (cross-over design, multiple measurements)	calcification score derived from several pro- and anticalcifying biomarkers

Trial Locations

Locations (1)

Department of nephrology, Klinikum rechts der Isar; 🇩🇪 München, Bavaria, Germany