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| Name | Class |
|---|---|
| Lund University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First MCO-HD, then High-flux-HDF | Active Comparator | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCO-HD | Device | Measurements will be done during a single hemodialysis session with Medium Cut-Off filter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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% | 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. | 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. | 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. | 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. | 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| RR of large molecules (Albumin, Transferrin, IgG) | Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100% | 4 hours |
| RR of small molecules (Urea, Phosphate, Creatinine) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Christensson, MD, PhD | Region Skane, Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skane University Hospital | Malmö | Sweden |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D014511 | Uremia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| High-flux HDF | Device | Measurements will be done during a single hemodiafiltration session with standard high-flux filter |
|
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%
| 4 hours |
| Number of Adverse Events | Number of adverse events during a 4h dialysis session | 4 hours |
| Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG) | Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis. | 30 minutes |
| Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG) | Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis. | 60 minutes |
| Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG) | Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis. | 120 minutes |
| Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG) | Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis. | 240 minutes |
| Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine) | Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis. | 30 minutes |
| Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine) | Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis. | 60 minutes |
| Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine) | Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis. | 120 minutes |
| Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine) | Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis. | 240 minutes |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |