The main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in the United States.
The in-vivo KUF for Diacap Pro High Flux dialysers with the surface sizes of 1.3/ 1.6/ 1.9 sqm will be determined as required by the US guideline "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers 1998" for comparison with the in-vitro KUF data. Clinical data of at least 12 patients will be collected for determination of the in-vivo KUF complemented by safety-, performance-data for the removal of small and middle molecular substances and hemocompatibility data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
During dialysis treatment ultrafiltration rate will be changed following a fixed schedule and resulting changes in Transmembrane Pressure (TMP) recorded to generate data for calculation of the in-vivo KUF.
Interní oddělení Strahov VFN
Prague, Czechia
Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF)
UF-rates will be changed over a range starting from 600 ml/min to 1000 ml/min to 1400 ml/min to finally 1800 ml/min and resulting changes in Transmembrane Pressure (TMP) will be documented.
Time frame: For two of three dialysis sessions each week for a total study period of six weeks
Clearance data dialyzer [ml/min]
For ß2M; Myoglobin; Retinol-Binding-Protein; alpha-1-Microglobulin; Albumin clearance data will be assessed by using serum samples pre- and post dialyzer at timepoints t=0 and t=240 min.
Time frame: For one of six dialysis sessions each two weeks for a total study period of six weeks
Reduction rates dialyzer [%]
For urea; creatinine; phosphate; ß2-Microglobulin; Myoglobin; Retinol-Binding-Protein; alpha-1 Microglobulin and Albumin reduction rates will be calculated by using serum-levels at timepoints t=0 and t=240 min.
Time frame: For two of three dialysis sessions each week for a total study period of six weeks
Total removal of proteins [mg/session]
Spent dialysate will be collected during the entire dialysis treatment. Considering dialysate flow rate and ultrafiltration volume concentration of ß2-Microglobulin; Myoglobin; Retinol-Binding-Protein;alpha-1 Microglobulin; Albumin; Total Protein will be used to calculate total removal by multiplying with the effective spent dialysate volume
Time frame: For one of six dialysis sessions each two weeks for a total study period of six weeks
Complement-activation C3a and C5a [ng/ml]
For complement activation C3a \[ng/ml\]; C5a \[ng/ml\] will be assessed at timepoints t=0, t=15; t=60; t=240 min.
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Time frame: For one of six dialysis sessions each two weeks for a total study period of six weeks
Complement-activation TAT III [µg/l]
For complement activation TAT III \[µg/l\] will be assessed at timepoints t=0, t=15; t=60; t=240 min.
Time frame: For one of six dialysis sessions each two weeks for a total study period of six weeks
Inflammatory response Interleukin-1, Interleukin-6 and TNF-alpha [pg/ml]
For inflammatory response Interleukin-1 \[pg/ml\]; Interleukin-6 \[pg/ml\]; TNF-alpha will be assessed at timepoints t=0; t=15; t=60; t=240 min
Time frame: For one of six dialysis sessions each two weeks for a total study period of six weeks
Inflammatory response CRP [mg/l]
For inflammatory response CRP\[mg/l\] will be assessed at timepoints t=0; t=15; t=60; t=240 min
Time frame: For one of six dialysis sessions each two weeks for a total study period of six weeks
Incidence of Treatment-Emergent Adverse Events
Number of patients presenting adverse events will be assessed following CTCAE v4.0 grading.
Time frame: November 2016 up to 2 months