The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis with medium cut-off polyarylethersulphone-polyvinylpirrolidone membrane (Theranova®).
The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis (HD) with PES-PVP membrane. The research will be performed as a prospective clinical trial and will include 35 patients. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate. We will compare the efficiency of both types of anticoagulation by measuring overall and instantaneous clearances of small, middle and protein-bound molecules (urea, creatinine, phosphate, β2-microglobulin, p-cresol). Biocompatibility will be evaluated by measuring activation of: complement (serum concentration of C3a and C5a), leukocytes (serum concentration of myeloperoxidase) and thrombocytes (serum concentration of PF4). We will also monitor complete blood count for occurrence of leukopenia and thrombocytopenia. After the HD electron microscopy of the membrane will be done in the proportion of included patients to evaluate adsorption of cells and formation of blood clots on the membrane.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
A bolus of 30 I.U./kg at the start of hemodialysis, followed by 18 I.U./kg per every hour of hemodialysis.
8% trisodium citrate in the dose of 150 ml/h.
University Medical Centre Ljubljana
Ljubljana, Slovenia
Clearance of beta-2 microglobulin
Overall and instantaneous clearance of beta-2 microglobulin.
Time frame: At the end of each hemodialysis procedure.
Clearance of phosphate
Overall and instantaneous clearance of phosphate.
Time frame: At the end of each hemodialysis procedure.
Serum concentration of C3a, C5a, myeloperoxidase and PF-4
Blood for the laboratory measurements will be taken from the arterial line.
Time frame: At the start, after 15 minutes and at the end of each hemodialysis procedure.
Clearance of urea
Overall and instantaneous clearance of urea.
Time frame: At the end of each hemodialysis procedure.
Clearance of creatinine
Overall and instantaneous clearance of creatinine.
Time frame: At the end of each hemodialysis procedure.
Clearance of p-cresol
Overall and instantaneous clearance of p-cresol.
Time frame: At the end of each hemodialysis procedure.
White blood cell count
Blood for the laboratory measurements will be taken from the arterial line.
Time frame: At the start, after 15 minutes and at the end of each hemodialysis procedure.
Blood platelet count
Blood for the laboratory measurements will be taken from the arterial line.
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Time frame: At the start, after 15 minutes and at the end of each hemodialysis procedure.