Renal Failure Chronic Requiring Hemodialysis
Conditions
Brief summary
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
Interventions
OTHERDialyzer comparison
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.
Sponsors
Gambro Dialysatoren GmbH
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chronic renal failure and stable treatment with hemodialysis or hemodiafiltration for at least 3 months * patients aged 18 years or more * written consent to participate in the study (informed consent) * dialysis via native fistula or Gore-Tex graft capable of providing a blood flow rate of at least 300 mL/min
Exclusion criteria
* single-needle dialysis * pregnant and lactating women * participation in other interventional studies less than 3 months prior to study start * non-compliance with the dialysis prescription * hematocrit less than 28% * hospitalization * antibiotic therapy * active infection * active cancer * known positive serology for HIV, hepatitis B or C * serious hemostasis disorders * any comorbidity possibly conflicting with the study purpose or procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis dose Kt/V urea | 2 weeks (6 consecutive dialysis sessions) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction rate of urea, creatinine, phosphate and ß2-microglobulin | 2 weeks (6 consecutive dialysis sessions) | Calculation from pre and post dialysis plasma concentrations. Unit of measure is percentage (%). |
| Total removal of creatinine, phosphate and ß2-microglobulin | 2 weeks (6 consecutive dialysis sessions) | 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. |
| Albumin loss | 2 weeks (6 consecutive dialysis sessions) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood count | 2 weeks (start and end of 6 consecutive dialysis sessions) | Parameters are hemoglobin concentration (g/dL), hematocrit (%), thrombocyte concentration (G/L), erythrocyte concentration (T/L), leukocyte concentration (G/L). |
Countries
Austria
Outcome results
None listed