An interventional study of MCO-HD and High-flux HDF in Chronic Kidney Failure, Uremia and Dialysis, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Region Skane · Not applicable, Interventional, and Treatment
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 18 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
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Exclusion Criteria:
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
Device: MCO-HD · Device: 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
Device: MCO-HD · Device: High-flux HDF
Measurements will be done during a single hemodialysis session with Medium Cut-Off filter
Measurements will be done during a single hemodiafiltration session with standard high-flux filter
Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration\*100%
Time frame: 4 hours
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Time frame: 30 minutes
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Time frame: 60 minutes
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
Time frame: 120 minutes
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.
Time frame: 240 minutes
RR of large molecules (Albumin, Transferrin, IgG)
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration\*100%
Time frame: 4 hours
RR of small molecules (Urea, Phosphate, Creatinine)
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration\*100%
Time frame: 4 hours
Number of Adverse Events
Number of adverse events during a 4h dialysis session
Time frame: 4 hours
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Time frame: 30 minutes
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Time frame: 60 minutes
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
Time frame: 120 minutes
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.
Time frame: 240 minutes
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Time frame: 30 minutes
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Time frame: 60 minutes
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
Time frame: 120 minutes
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.
Time frame: 240 minutes
Plan to share: No
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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