Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter

Not Applicable

Completed

• Conditions: Chronic Kidney Failure; Dialysis; Uremia
• Interventions: Device: MCO-HD; Device: High-flux HDF

• Registration Number: NCT03437538
• Lead Sponsor: Region Skane

Brief Summary

The Medium Cut-Off dialysis (MCO) membrane has been developed to improve middle molecule removal compared to standard high-flux dialysis filters.

The major aim of this study is to compare the reduction ratio of middle molecules, during a single hemodialysis session with MCO-filter, compared to hemodiafiltration (HDF) with standard high-flux filter.

Secondary aims are to compare the reduction ratio of small and large molecules between the treatments.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-19
• Study Start: 2018-05-21
• Primary Completion: 2019-04-16
• Study Completion: 2019-04-16
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Ongoing HDF treatment
• CRP <30
• No Acute Myocardial Infarction within 3 months.

Exclusion Criteria

• Not able to understand the study information.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First High-flux-HDF, then MCO-HD	MCO-HD	Participants with ongoing HDF-treatments will have measurements during a 4h dialysis with High-flux-HDF, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during an intervention with a 4h dialysis with MCO-HD
First MCO-HD, then High-flux-HDF	MCO-HD	Participants with ongoing HDF-treatments will have measurements during an intervention with a 4h dialysis with MCO-HD, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during a 4h dialysis with High-flux-HDF
First MCO-HD, then High-flux-HDF	High-flux HDF	Participants with ongoing HDF-treatments will have measurements during an intervention with a 4h dialysis with MCO-HD, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during a 4h dialysis with High-flux-HDF
First High-flux-HDF, then MCO-HD	High-flux HDF	Participants with ongoing HDF-treatments will have measurements during a 4h dialysis with High-flux-HDF, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during an intervention with a 4h dialysis with MCO-HD

Primary Outcome Measures

Name	Time	Method
Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)	4 hours	Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration\*100%
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)	240 minutes	Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events	4 hours	Number of adverse events during a 4h dialysis session
RR of large molecules (Albumin, Transferrin, IgG)	4 hours	Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration\*100%
RR of small molecules (Urea, Phosphate, Creatinine)	4 hours	Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration\*100%
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)	240 minutes	Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)	240 minutes	Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.

Trial Locations

Locations (1)

Skane University Hospital; 🇸🇪 Malmö, Sweden