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This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off(MCO) Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
Patients who are initially on High Flux Dialyser will be randomised into either MCO Dialyser (modality A) or High Flux Dialyser (modality B) dialysate. The dialysate flow (QD) and blood flow (QB) remains unchanged throughout study period. After 12 treatments (4 weeks) a 4-weeks wash-out phase using High-flux dialyzers was performed to minimize carry-over-effects. After the 4-weeks washout phase, the modality is switched to the alternative one for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCO Dialyser | Experimental | 12 treatments (4 weeks) with Medium Cut-Off Dialyzer |
|
| High Flux Dialyser | Active Comparator | 12 treatments (4 weeks) with High Flux Dialyzer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theranova 400 | Device | medium cut-off dialyser |
| |
| Elisio-19H |
| Measure | Description | Time Frame |
|---|---|---|
| Removal of Beta-2-microglobulin | Changes to Beta-2-microglobulin level | 4 weeks |
| Changes to Quality of Life | Changes to Quality of life Using SF-36 | 27 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory state after intervention | Changes to C-Reactive Protein Level | 4 weeks |
| Changes to Quality of Life | Changes to Quality of life Using EQ-5D-5L |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hin Seng Wong, MD | Ministry of Health, Malaysia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Selayang Hospital | Batu Caves | Selangor | 68100 | Malaysia |
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This is an open label, cross-over group, single-centre randomised controlled trial comparing MCO Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
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| Device |
high flux dialyser |
|
| 27 weeks |