Abstract:Background
Dialyzers shall be designed to efficiently eliminate uremic toxins during a dialysis treatment, given that the accumulation of small and middle molecular weight uremic solutes is associated with increased mortality risk of patients with end-stage renal disease. In the present study we investigated the novel FX CorAL dialyzer with a modified membrane surface for the performance during online-hemodiafiltration in a clinical setting.
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“…Moreover, comPERFORM investigated the amount of albumin, which was lost into the dialysate during the treatment sessions. Here, in line with our present experimental data, xevonta showed the highest albumin loss after 4 h (1.53 ± 0.80 g), followed by FX CorAL (1.36 ± 0.71 g) and ELISIO (1.10 ± 0.60 g) 22 . Of note, the total amount of albumin loss was higher in the clinic than in the present experimental setting.…”
Section: Discussionsupporting
confidence: 92%
“…We investigated the three dialyzers FX CorAL (Fresenius Medical Care), ELISIO (Nipro), and xevonta (B. Braun) used in the clinical study comPERFORM (Comparative Clinical Performance of Dialyzers Applied During High Volume Online Hemodiafiltration, NCT04102280). 22 Table 1 summarizes information for dialyzers according to Nalesso et al, 23 for the following categories: Membrane/Area, Coefficients, Clearances, Sieving Coefficients, and Modality. For the categories SC-MW (molecular weight retention onset and molecular weight cut-off) and RR (middle and high molecular weight reduction rate) the manufacturers provide no information in the respective instructions for use or brochures.…”
Background: Toxin removal capacity (i.e., performance) of a dialyzer is not constant but diminishes during treatment, as the adsorption of proteins to the membrane provides an additional barrier to uremic solutes. We investigated timeresolving molecular weight retention changes among synthetic high-flux dialyzers and compared the results with recent data from a randomized controlled trial.
Methods:In plasma recirculation experiments over 240 min, sieving coefficients (SC) for β2microglobulin, myoglobin, and albumin were determined for the FX CorAL (Fresenius Medical Care), ELISIO (Nipro), and xevonta (B. Braun).Molecular weight retention (MWR) curves were generated and the shifts over 120 min were characterized. Effective pore radius was determined, and the predicted albumin loss was compared with clinical data.Results: SC decreased over time for all dialyzers (mean relative decrease across all dialyzers: β2-microglobulin: 8.0% (120 min); myoglobin: 56.6% (240 min); albumin: 94.1% (240 min)). FX CorAL (7.3%, 52.6% and 91.1%) and ELISIO (7.7%, 51.0%, and 93.8%) showed a lower decrease than xevonta (9.0%, 66.2%, and 97.4%).For all dialyzers, MWR curves shifted toward lower molecular weight, with the lowest shift for FX CorAL (by 0.23 nm at SC50%, 120 min) and highest for xevonta (0.50 nm). FX CorAL had the highest slope over time and the smallest decrease in the effective pore radius (2 min: 2.31 nm, 120 min: 2.08 nm). Predicted albumin loss over 4 h was highest for xevonta (609.3 mg) and comparable between ELISIO (283.6 mg) and FX CorAL (313.3 mg).Conclusions: Substantial differences in the temporal performance profile of dialyzers exist. The present approach allows the characterization of dialyzer permeability changes over time using standard, clinically relevant protein markers.
“…Moreover, comPERFORM investigated the amount of albumin, which was lost into the dialysate during the treatment sessions. Here, in line with our present experimental data, xevonta showed the highest albumin loss after 4 h (1.53 ± 0.80 g), followed by FX CorAL (1.36 ± 0.71 g) and ELISIO (1.10 ± 0.60 g) 22 . Of note, the total amount of albumin loss was higher in the clinic than in the present experimental setting.…”
Section: Discussionsupporting
confidence: 92%
“…We investigated the three dialyzers FX CorAL (Fresenius Medical Care), ELISIO (Nipro), and xevonta (B. Braun) used in the clinical study comPERFORM (Comparative Clinical Performance of Dialyzers Applied During High Volume Online Hemodiafiltration, NCT04102280). 22 Table 1 summarizes information for dialyzers according to Nalesso et al, 23 for the following categories: Membrane/Area, Coefficients, Clearances, Sieving Coefficients, and Modality. For the categories SC-MW (molecular weight retention onset and molecular weight cut-off) and RR (middle and high molecular weight reduction rate) the manufacturers provide no information in the respective instructions for use or brochures.…”
Background: Toxin removal capacity (i.e., performance) of a dialyzer is not constant but diminishes during treatment, as the adsorption of proteins to the membrane provides an additional barrier to uremic solutes. We investigated timeresolving molecular weight retention changes among synthetic high-flux dialyzers and compared the results with recent data from a randomized controlled trial.
Methods:In plasma recirculation experiments over 240 min, sieving coefficients (SC) for β2microglobulin, myoglobin, and albumin were determined for the FX CorAL (Fresenius Medical Care), ELISIO (Nipro), and xevonta (B. Braun).Molecular weight retention (MWR) curves were generated and the shifts over 120 min were characterized. Effective pore radius was determined, and the predicted albumin loss was compared with clinical data.Results: SC decreased over time for all dialyzers (mean relative decrease across all dialyzers: β2-microglobulin: 8.0% (120 min); myoglobin: 56.6% (240 min); albumin: 94.1% (240 min)). FX CorAL (7.3%, 52.6% and 91.1%) and ELISIO (7.7%, 51.0%, and 93.8%) showed a lower decrease than xevonta (9.0%, 66.2%, and 97.4%).For all dialyzers, MWR curves shifted toward lower molecular weight, with the lowest shift for FX CorAL (by 0.23 nm at SC50%, 120 min) and highest for xevonta (0.50 nm). FX CorAL had the highest slope over time and the smallest decrease in the effective pore radius (2 min: 2.31 nm, 120 min: 2.08 nm). Predicted albumin loss over 4 h was highest for xevonta (609.3 mg) and comparable between ELISIO (283.6 mg) and FX CorAL (313.3 mg).Conclusions: Substantial differences in the temporal performance profile of dialyzers exist. The present approach allows the characterization of dialyzer permeability changes over time using standard, clinically relevant protein markers.
“…Membranes with a thicker protein layer have a stronger reduction in performance, which is associated with stronger reduction in the effective pore size of the dialyzer membranes [ 58 , 60 ]. Data from a recent randomized controlled trial with 52 hemodialysis patients treated with three different synthetic dialyzers in a cross-over design, support these findings, showing superiority in β2-microglobulin removal rate for that dialyzer that had the lowest secondary membrane formation (75.5% vs. 74.0% and 72.7%; p = 0.0216 and p < 0.0001, respectively) [ 37 ]. Therefore, these blood-membrane interactions influence the efficacy of the dialysis treatment and have to be taken into considerations beyond the clearance values presented in the instructions for use of the dialyzers.…”
Section: Impact Of Membrane Fouling On Dialyzers’ Performance and Hem...mentioning
confidence: 87%
“…Repeated protein loss may lead to the development of malnutrition, which is associated with increased mortality among ESKD patients [ 34 , 35 , 36 ]. Therefore, albumin has become an established key parameter of nutritional status of hemodialysis patients and has also been used in studies investigating protein leakage into the dialysate [ 37 ]. Thus, the performance of a dialyzer is not sufficiently described by its clearance or removal of middle size toxins and should consider its sieving properties overall, including its permeability cut-off for larger size proteins.…”
Section: The Importance Of Dialyzer Performance and Hemocompatibility...mentioning
The dialyzer is the core element in the hemodialysis treatment of patients with end-stage kidney disease (ESKD). During hemodialysis treatment, the dialyzer replaces the function of the kidney by removing small and middle-molecular weight uremic toxins, while retaining essential proteins. Meanwhile, a dialyzer should have the best possible hemocompatibility profile as the perpetuated contact of blood with artificial surfaces triggers complement activation, coagulation and immune cell activation, and even low-level activation repeated chronically over years may lead to undesired effects. During hemodialysis, the adsorption of plasma proteins to the dialyzer membrane leads to a formation of a secondary membrane, which can compromise both the uremic toxin removal and hemocompatibility of the dialyzer. Hydrophilic modifications of novel dialysis membranes have been shown to reduce protein adsorption, leading to better hemocompatibility profile and performance stability during dialysis treatments. This review article focuses on the importance of performance and hemocompatibility of dialysis membranes for the treatment of dialysis patients and summarizes recent studies on the impact of protein adsorption and hydrophilic modifications of membranes on these two core elements of a dialyzer.
“…Moreover, all these bone-derived products, whose levels achieve even 1000-fold above the physiological limit in HD patients, belong to the group of uremic toxins. Current strategies decrease their serum concentration through dietary and pharmacological interventions, mainly via modulation of intestinal absorption capacity through binding effects and/or reduction of ingested amounts of the toxins or their precursors, and by extra-corporeal removal [ 18 , 19 ].…”
Morbidity and mortality have marginally decreased over the last 3 decades in hemodialyzed (HD) patients, despite multiple pharmacological and technological interventions [...]
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