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| Name | Class |
|---|---|
| Gambro Dialysatoren GmbH | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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The purpose of the study is to show equivalent performance of the Revaclear dialyzer when compared to a dialyzer with larger membrane surface area.
Study design: open, randomized, cross-over, multicentric, controlled prospective
Medical devices: Revaclear 200 versus FX 60 or Revaclear 400 versus FX 100, depending on patient needs
Patients/sample size: 30 adult chronic hemodialysis patients
Treatment: Each patient will be treated by hemodialysis for one week (3 dialysis sessions) with Revaclear dialyzers and one week (3 dialysis sessions) with FX dialyzers.
Objectives: intraindividual comparison of dialysis dose; reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin; albumin loss
Primary variable: dialysis dose Kt/V urea
Secondary variable: reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin
Safety variable: albumin loss, blood count
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revaclear followed by FX | Other |
| |
| FX followed by Revaclear | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialyzer comparison | Other | Each patient is treated by hemodialysis for one week (3 sessions) with each dialyzer type (Revaclear or FX). The order of dialyzers used will be randomly assigned to the patient at randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Dialysis dose Kt/V urea | Calculation from pre and post plasma urea concentration or urea nitrogen, session length, ultrafiltration volume and post dialysis weight. Dialysis dose does not have a unit of measure. | 2 weeks (6 consecutive dialysis sessions) |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction rate of urea, creatinine, phosphate and ß2-microglobulin | Calculation from pre and post dialysis plasma concentrations. Unit of measure is percentage (%). | 2 weeks (6 consecutive dialysis sessions) |
| Total removal of creatinine, phosphate and ß2-microglobulin |
| Measure | Description | Time Frame |
|---|---|---|
| Blood count | Parameters are hemoglobin concentration (g/dL), hematocrit (%), thrombocyte concentration (G/L), erythrocyte concentration (T/L), leukocyte concentration (G/L). | 2 weeks (start and end of 6 consecutive dialysis sessions) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Rosenkranz, Prof. | Medical University Graz, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dialyseinstitut Prim. Dr. W. Gießauf GmbH | Graz | 8010 | Austria | |||
| Medical University Graz |
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Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment. |
| 2 weeks (6 consecutive dialysis sessions) |
| Albumin loss | Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment. | 2 weeks (6 consecutive dialysis sessions) |
| Graz |
| 8036 |
| Austria |