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The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.
Hemodiafiltration, a convective-based therapy combining both diffusive and convective transports appears as the treatment modality of choice for hemodialysis patients. Indeed, this innovative technique offers an effective dialysis modality removing spectrum of uremic solutes with an optimized biocompatibility of the extracorporeal circuit obtained with use of ultrapure dialysis and sterile substitution fluids. However, such therapy can not be proposed in all dialysis centers due to major drawbacks of this technique over conventional hemodialysis, the complexity of the system and its increased costs. Alternatively, enhancement of convective transport may now be achieved by use of innovative dialyzers allowing more internal filtration. This is the case of ELISIOâ„¢-H dialyzers which possess fibers of a greater internal length which potentially allow more internal filtration. Aim of the present study was therefore to evaluate efficacy and biocompatibility of internal filtration-enhanced hemodialysis using this dialyzer compared to hemodiafiltration, over a four-month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elisio-210H with HD | Experimental | hemodialysis patients treated with conventional hemodialysis (HD) modality using Elisio-210H dialyzer |
|
| Elisio-210H with on line HDF | Active Comparator | hemodialysis patients treated with on line hemodiafiltration (HDF) modality using Elisio-210H dialyzer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elisio-210H | Device | comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration |
|
| Measure | Description | Time Frame |
|---|---|---|
| pre-dialytic serum beta-2 microglobulin level | Month 1 (after one month) |
| Measure | Description | Time Frame |
|---|---|---|
| reduction rate of low molecular weight solutes (urea and creatinine) | Month 0, 1, 2, 3, 4 | |
| dialysis dose (urea KT/V) | Month 0, 1, 2, 3, 4 | |
| instantaneous clearance of low molecular weight solutes (urea and creatinine) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard CANAUD, MD, Prof. | University Hospital Center of Montpellier, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Center | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| conventional hemodialysis | Procedure | comparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer |
|
| on line hemodiafiltration | Procedure | comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer |
|
| Month 0, 1, 2, 3, 4 |
| inflammatory markers (CRP, fibrinogen, orosomucoide) | month 0, 1, 2, 3, 4 |
| inflammatory marker (interkeukin 6) | month 0, 4 |
| nutritional status (albumin, transthyretin, homocysteine) | Month 0, 1, 2, 3, 4 |
| endothelial progenitor cells | Month 0, 1, 2, 3, 4 |
| inflammatory mononuclear cell activation | Month 0, 1, 2, 3, 4 |
| kappa and lambda light chains | Month 0, 4 |
| oxidative stress parameters (superoxide anion, AOPPs, AGEs) | Month 0, 4 |
| coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII) | Month 0, 4 |
| apoptosis markers (soluble FAS and FAS ligand) | Month 0, 4 |
| bone markers (bone PAL, Cross Laps, TRAP5b) | Month 0, 4 |
| 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 |