Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type. Study objectives: Intraindividual comparison of removal rate of urea, phosphate, ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during post-dilution online hemodiafiltration. Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea, phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
30
Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type (FX CorDiax 60or FX 60 ) The order of dialyzers used will be randomly assigned to the patient at the time of randomisation by lot. Every subject will be treated one time with each dialyzer. In order to achieve controlled conditions, the mid- or end-week session data will be used, only.
Comparison Dialyzer FX60 versus Cordiax60
Hospital Clínic
Barcelona, Barcelona, Spain
Removal rate of myoglobin
Time frame: 2 weeks
Removal rate of urea
Time frame: 2 weeks
Removal rate of phosphate
Time frame: 2 weeks
Removal rate of ß2-microglobulin (ß2-m)
Time frame: 2 weeks
Removal rate of prolactin
Time frame: 2 weeeks
Removal rate of alpha1-microglobulin
Time frame: 2 weeks
Removal rate of alpha1-acid glycoprotein
Time frame: 2 weeks
Hematocrit pre and post-dialysis
Time frame: 2 weeks
Albumin loss during dialysis session
Time frame: 2 weeks
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