Efficacy of Medium Cut-Off Dialyzer and Comparison with Standard High-Flux Hemodialysis

2020 ◽  
pp. 1-7
Author(s):  
Irena Rambabova Bushljetik ◽  
Lada Trajceska ◽  
Sefedin Biljali ◽  
Trajan Balkanov ◽  
Petar Dejanov ◽  
...  

<b><i>Background:</i></b> A new medium cut-off (MCO) membranes has been designed to achieve better removal capacities for middle and large middle molecules in hemodialysis (HD) treatment. <b><i>Aim:</i></b> The aim of this study was to evaluate the removal efficacy of Theranova® in standard HD in comparison with standard high-flux HD. <b><i>Methods:</i></b> Four HD patients (M/F 1/4) were included in 12-week observational pilot study in HD with Theranova® 400 and Theranova® 500 dialyzers. Each patient was assessed 4 times, <i>T</i><sub>0</sub> with high-flux dialyzers, <i>T</i><sub>1</sub> at 1 month, <i>T</i><sub>2</sub> at second month, and <i>T</i><sub>3</sub> at third month, by measuring pre- and post-HD samples of urea, Cr, β2-microglobilin (β2M), myoglobin, albumin, free light chains kappa (FLC-k), and free light chains lambda (FLC-λ). <b><i>Results:</i></b> The data showed a higher average removal rate for all the uremic toxins with Theranova® dialyzers for β2M, myoglobin, FLC-k, and FLC-λ (62.7, 56.9, 63.5, and 54.6%, respectively) during the 3 months. Albumin retention was observed and did not change between <i>T</i><sub>0</sub> and <i>T</i><sub>3</sub> (<i>p</i> = 0.379). <b><i>Conclusion:</i></b> Compared to high-flux membranes, MCO membranes show greater permeability for middle molecules in midterm report.

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Irena Rambabova Bushljetikj ◽  
Lada Trajcheska ◽  
Vladimir Pushevski ◽  
Sefedin Biljali ◽  
Trajan Balkanov

Abstract Background and Aims Hemodialysis (HD) is the most widely used modality of renal replacement therapy. The high-flux dialyzers in standard hemodialysis offer numerous benefits for ESRD patients, such as, increasing the uremic toxins removal and improving patients survival, reduced patients admission and morbidity. A new class of membranes, medium cut-off (MCO) membranes, has been designed to achieve better removal capacities for middle and large middle molecules, as well as to ensure the retention of albumin in hemodialysis (HD) treatments. We evaluated the removal efficacy of Theranova® in standard HD in comparison with standard high- flux HD. Method Four stable HD patients (M/F 1/4) were included in 12-weeks small observational pilot study in HD with Theranova® 400 (sup. 1.7 m2) and Theranova® 500 (sup. 2.0 m2) dialyzers. Each patient was assessed four times, T0 with standard high flux dialyzers, T1 at 1 month, T2 at second month and T3 at third month, by measuring pre and post-HD samples of: urea, creatinine, beta2-microglobilin (B2M), myoglobin, albumin and FLC-k, FLC-λ . Data are reported as mean ± standard deviation (SD). The removal rates of uremic toxins are expressed as percentages. Results The average removal rates for the uremic toxins with standard high-flux membranes were 18.4% for B2M, 14.3% for Myoglobin, 19.8 % for FLC-k and 17.4 % for FLC-λ. The data showed a higher average removal rate for all the uremic toxins with Theranova® dialyzers for B2M, Myoglobin, FLC-k and FLC-λ (62.7%, 56.9%, 63.5%, 54.6%, respectively) during the 3 months of follow up. The using of Theranova® dialyzers in standard HD was enough to significantly decrease the pre-dialysis value of Urea (17.72 ± 2.26 vs 13.75 ± 3.75, p=0.001), Creatinine (700.50 ± 315.07 vs 570.00 ± 206.64, p=0.021), B2M (40.90 ± 11.00 vs 29.00 ± 4.64, p=0.005), FLC-k (267.25 ± 113.28 vs 225.25 ± 100.62, p=0.018), FLC-λ (324.25 ± 116.12 vs 215.23 ± 64.44, p=0.011), Myoglobin ( 199.96 ± 124.41 vs 137.00 ± 83.14, p= 0.049). Finally, albumin retention was observed with Theranova® dialyzers, between T0 and T3 it increased significantly (40.50 ± 4.79 vs 42.25 ± 4.50, p=0.0001). Conclusion Compared to high-flux dialysis membranes, novel medium cut-off (MCO) membranes show greater permeability for larger middle molecules in mid -term report. But the long term analysis and larger number of patients is necessary to evaluate a clinical significance of this innovative therapy.


BMC Cancer ◽  
2007 ◽  
Vol 7 (1) ◽  
Author(s):  
B Hildebrandt ◽  
C Müller ◽  
A Pezzutto ◽  
PT Daniel ◽  
B Dörken ◽  
...  

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e19530-e19530
Author(s):  
Hamza Hassan ◽  
Abdul Rafae ◽  
Nimra Iftikhar ◽  
fateeha furqan ◽  
Ahmad Iftikhar ◽  
...  

e19530 Background: Renal impairment (RI) in Multiple Myeloma (MM) adversely affects the prognosis. Removing circulating free light chains via hemodialysis (HD) or plasma exchange (PLEX) along with chemotherapy can improve renal outcomes in MM. Methods: Per PRISMA guidelines a systematic search yielded 7311 articles since 2009 on 4 databases. After screening, 16 studies were included. Results: Main modalities were high cut off (HCO) HD, high flux (HF) HD, conventional HD and PLEX. N = 541 patients underwent HD/PLEX. 375/541 (69.3%) patients received HCO HD. In 2 RCTs, there was no significant difference in renal recovery (55.8% vs 51.6%; 41% vs 33%). The overall survival (OS) between the 2 groups was lower in the HCO group vs conventional HD (55.8% vs 76.6%) at 2 years while there was no significant difference in second study. Conclusions: HCO has failed to show promising efficacy with 2 RCTs failing to show statistical OS difference. There is paucity of data and further trials are needed. [Table: see text]


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Jong Hwan Jung ◽  
Seon-Ho Ahn ◽  
Ju Hung Song

Abstract Background and Aims Protein-bound toxins and uremic toxins with middle molecular weight usually develop uremic symptoms in patients with advanced chronic kidney disease (CKD) or end-stage renal disease (ESRD). Although the effect on uremic toxicity of the molecules is not proven yet, middle molecules or larger middle molecules is regarded with important substance concerning of development of uremic symptoms and cardiovascular complication, particularly in CKD patients. Hemodialysis (HD) or hemodiafiltration (HDF) using dialyzer with high flux membrane provided improved clearance for uremic toxins with middle molecular weights. However, uremic toxins with larger middle molecular weight could not be easily removed through above methods. Medium cut-off (MCO) membrane can remove larger middle molecules which can be not removed through high flux membrane and HDF. From this perspective, chronic use of MCO membrane lowering the plasma concentration of larger middle molecules associated with cardiovascular complications including vascular calcification may give beneficial effect, particularly in patients with ESRD. Method Twenty-five patients undergoing chronic hemodialysis were prospectively analyzed for 6 months. We randomly divided enrolled patients into two groups: control group and MCO group. Patients in the control group used dialyzer with high flux membrane and patients in MCO group used dialyzer with MCO membrane. The enrolled patients performed hemodialysis thrice a week during 6 months. We measured plasma levels of several biomarkers at baseline and 3-month and 6-month through the multiplexing using Luminex® technology. In this prospective study, we performed comparative analysis with larger middle molecules, such as CXCL16, sclerostin, and FGF-23, in both groups. Results The plasma levels of all biomarkers at baseline did not show significant difference between two groups (CXCL16: p =0.904, Sclerostin: p =0.322, FGF-23: p =0.065, respectively). However, plasma sclerostin levels at 3-month and 6-month were significantly lower in MCO group (p = 0.060, p &lt;0.005, respectively). In addition, even after analysis of covariance through ANCOVA analysis, plasma sclerostin levels at 3-month and 6-month were significantly lower in MCO group compared with the control group (p = 0.042, p =0.001, respectively). But, there was no a significant decrease of plasma sclerostin levels according to time, particularly in MCO group (p = 0.157, p =0.412, respectively) (Figure 1). Conclusion This study showed the 6-month outcome for changes of the plasma levels of larger middle molecules, including CXCL16, sclerostin, and FGF-23, particularly in dialytic patients using dialyzer with MCO membrane. Plasma sclerostin associated with vascular calcification showed decreasing tendency during 6 months after application of MCO membrane, but, there was no statistical significance. However, plasma levels of sclerostin were significantly lower in dialytic patients using MCO membrane than those using high flux membrane at 3 and 6 months, respectively. Therefore, hemodialysis using dialyzer with MCO membrane may be an option to attenuate cardiovascular complications in ESRD patients.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Fernando Hadad Arrascue ◽  
Lars-Göran Nilsson ◽  
Angelito Bernardo ◽  
Angela Rivera ◽  
Lourdes Guardiola Belmonte, ◽  
...  

Abstract Background and Aims Expanded hemodialysis (HDx) with a medium cut-off dialyzer, Theranova® 500, can achieve a middle molecule clearance but its efficacy or comparison with HDF is still unknown. It is still unknown on how large middle molecules and inflammation markers are affected over time with a medium cut-off dialyzer. This study compared the purifying effectiveness of Theranova® 500 dialyzer with respect to online Hemodiafiltration (OL-HDF). Method Sixty-three patients who were already receiving HDF were evaluated and 43 were randomized by residual renal function. Twenty-one patients received treatment with HDx using Theranova® 500 and 22 patients remained in HDF in post-dilution mode, using a high-flux dialyzer, Polyflux® 170H, for up to 24 weeks. The dialysis time and the adequacy parameters for both arms were the same. Large middle molecules were measured (kappa immunoglobulin free light chains [κ-FLC], lambda immunoglobulin free light chains [λ-FLC], chitinase-3-like protein 1 [YKL-40], fibroblast growth factor 23 [FGF-23] and serum beta-2 microglobulin [β2M]), ; and inflammatory markers (high sensitivity C-reactive protein [hs-CRP], pentraxin - 3 [PTX-3], interleukin-6 [IL-6], interleukin-10 [IL-10]) at 12 weeks of treatment; and its change from baseline to weeks 12 and 24 in mid-week pre-dialysis. The method of measurement was the immunoassay. Siemens immunoassay was used for FLCs. Results HDx with Theranova® 500 demonstrated comparable results to OL-HDF with convective volume 24.4±3.2 L in terms of reduction rate (RR) of middle molecules (κ-FLC, λ-FLC, FGF-23 and β2M) at 12 weeks of treatment. HDx demonstrated similar performance to HDF in mid-week pre-dialysis plasma levels of middle molecules from baseline, at 12 and 24 weeks of treatment. Greater RR of YKL-40 at 12 weeks of treatment was seen in HDx group when compared to HDF (58.1% vs 42.4%; p≤0.0001), and there was a difference in the pre-dialysis β2M change from Baseline values between the groups (-0.60 for HDx arm and +3.28 for HDF arm, p=0.46). HDx with Theranova® 500 demonstrated comparable results to HDF in terms of reduction rate (RR) of inflammatory markers (hs-CRP, PTX-3, IL-6 and IL-10) at 12 weeks of treatment. There were no differences in the parameters of adequacy of dialysis between both arms. Both treatments were effective in maintaining pre-dialysis albumin and fibrinogen levels throughout the study. There were no significant adverse events related to the safety of Theranova. Conclusion HDx with Theranova® 500 is an emergent, effective and safe hemodialysis therapy that showed a purifying efficacy at least comparable to OL-HDF.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 3482-3482 ◽  
Author(s):  
Arthur R. Bradwell ◽  
Neil D. Evans ◽  
Mike J. Chappell ◽  
Paul Cockwell ◽  
Steven D. Reid ◽  
...  

Abstract Introduction. Acute renal failure (ARF) develops in 10–15% of patients with multiple myeloma (MM). Typically, complexes of serum free light chains (sFLC) and Tamm-Horsfall protein form casts in the distal tubules that block urine flow. Many patients, subsequently, require long-term hemodialysis (HD) and may have reduced survival. In an attempt to minimise renal damage, plasma exchange (PE) has been used to reduce the pre-renal load of sFLC. Zucchelli et al., (Kidney Int1988; 33:1175–1180) showed that PE reduced HD requirements but subsequent controlled trials showed no benefit (Johnson WJ et al., Arch Intern Med1990; 150:863–869: Clarke WF et al., Haematologica2005; 90(s1) p117). The availability of sFLC immunoassays now allows an informed evaluation of the role of PE and/or HD in treating these patients. Methods. sFLC were measured in 1: 100 patients with chronic renal failure (CRF), GFR&lt; 15ml/min and not on dialysis; 2: 38 at the beginning and end of HD (dialyzer A) and 3: 25 on chronic ambulatory peritoneal dialysis (CAPD). sFLC hemofiltration efficiency was assessed, in-vitro, for three different dialyzers, using standard pump pressures and flow rates. Sera containing approximately 1,000 mg/L of monoclonal kappa (κ ) (NR &lt; 20mg/L) and lambda (λ ) FLC (NR &lt; 27mg/L) were recycled for ~45 minutes through the dialyzers and clearance rates assessed. A two-compartment, mathematical model was constructed to assess sFLC removal by HD and PE from hypothetical patients. The following parameters were considered:- sFLC concentrations in MM at clinical presentation; monomeric κ or dimeric λ clearance differences; partition of sFLC between vascular and extravascular compartments; flow of FLC between compartments; half-life of sFLC in ARF; sFLC production and tumour killing rates with chemotherapy. The model was interrogated for various dialysis times, different dialyzers and a PE protocol of 3L, x6 over 2 weeks. Results. Mean sFLC concentrations in severe CRF were: κ 93 mg/L (range 43–207); λ 64 mg/L (range 43–134). Mean sFLC before and after HD: κ 130 mg/L (range 40–567) to 49 (range 20–234); λ 100 mg/L (range 31–225) to 61 (range 24–159). Mean sFLC in CAPD patients: κ 118 mg/L (range 31–266); λ 114 mg/L (range 36–263). Clearances of sFLC by the 3 dialyzers were: A: BBraun high flux polyethersulfone 1.8sqm (HI PeS) (the dialyzer in routine use); κ 46%: λ 39%, B: Idmesa high flux polyethersulphone 2.0sqm (200MHP); κ 67%: λ 59%, C: Asahi high flux polysulphone 2.1sqm (APS 1050); κ 71%: λ 65%. Model calculations showed that sFLC reduced from a starting value of 14g/L (typical of light chain MM) to less than 0.5g/L in 14 days using PE. Membrane A, used for four hours, x3/week, was approximately 20% more efficient than PE and reduced κ sFLC approximately 50% faster than the natural clearance rate of patients in ARF. Dialyzers B and C were approximately twice as efficient. Performing initial, 16-hour dialyses daily for 3 days, with dialyzer C reduced sFLC to less than 0.5g/L in 2–3 days with ~95% of the sFLC being removed. Dimeric λ sFLC were removed ~50% more slowly. Conclusion. PE was less efficient at removing sFLC than routine HD. Prolonged HD with high-flux dialyzers removed monoclonal sFLC quickly and should be assessed in a clinical trial for patients with acute myeloma kidney. CAPD was inefficient at removing sFLC.


PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0258223
Author(s):  
Arkom Nongnuch ◽  
Chagriya Kitiyakara ◽  
Supawadee Sappadungsuk ◽  
Nuankanya Sathirapongsasuti ◽  
Kotcharat Vipattawat ◽  
...  

Background Dialysis patients have an increased risk of mortality. Recently treatment with haemodiafiltration (HDF) has been reported to reduce mortality, particularly cardiovascular mortality, compared to standard high-flux haemodialysis (HD). However, why HDF may offer a survival advantage remains to be determined. So, we conducted a pilot study to explore differences in middle-molecules, inflammation and markers of vascular disease in patients treated by HD and HDF. Methods Observational cross-sectional study measuring serum β2-microglobulin (β2M), Advanced Glycosylation End Products (AGEs) by skin autofluorescence (SAF), oxidative stress with ischaemia modified albumin ratio (IMAR) and peripheral vascular disease assessment using Ankle-Brachial Index (ABI), and arterial stiffness using Cardio-Ankle Vascular Index (CAVI). Results We studied 196 patients, mean age 69.1 ± 12.4 years, 172 (87.8%) treated by HD and 24 (12.2%) by HDF. Age, body mass index, co-morbidity and dialysis vintage were not different between HD and HDF groups. Middle molecules; β2M (31±9.9 vs 31.2±10 ug/mL) and SAF (2.99±0.72 vs 3.0±0.84 AU), ABI (1.06±0.05 vs 1.07±0.10) and CAVI (9.34±1.55 vs 9.35±1.23) were not different, but IMAR was higher in the HD patients (38.4±14.8 vs 31.3 ± 17.4, P = 0.035) Conclusions In this pilot observational study, we found patients treated by HDF had lower oxidative stress as measured by IMAR, with no differences in middle molecules. Lower oxidative stress would be expected to have diverse protective effects on the cardiovascular system Although we found no differences in ABI and CAVI, future studies are required to determine whether reduced oxidative stress translates into clinically relevant differences over time.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Ana Ostojic ◽  
Rodoljub Markovic

Abstract Background and Aims During last two decades there was a significant improvement in dialysis field, especially with introducement of high flux haemodialysis and on-line haemodiafiltration. In recent years, expanded haemodialysis has emerged as a new attempt to imrove effectiveness of dialysis. These so called medium cut-off membranes (MCO), allow removal of wider range of uremic toxins, especially middle weight molecules, most of which have important role in chronic inflammation and mortality. The aim of this prospective pilot study was to evaluate the effectiveness of middle molecules and other uremic toxins removal in patients treated with medium cut-off membrane (Theranova 500tm, Baxter), compared with patients on conventional high flux dialysis programme. Method We examined 10 patients on chronic haemodialysis programme, five of them dialyzed with Theranova 500tm dialyser for one year, and other five patients dialyzed with high flux membranes (polysulfone membrane, 1.8m2) during the same period. Patients were matched according to their age, sex, main disease, and the beginning of dialysis. Analyzed laboratory parameters were urea, creatinine, calcium, phosphorus, PTH, and hemoglobin, on the beginning of the study and after one year follow up, while hepcidin and β2 microglobulin levels were measured only in the end of follow up period. We used descriptive and analytic statistical methods (T test for independent and dependent means). Results Patients were divided in two groups, Group 1 - dialyzed with Theranova, and Group 2- patients on high flux haemodialysis, both followed during one year period (Group 1: 63.2±7.01 years, 3 males and 2 women, one of them with polycystic kidney disease (PCKD), the other four with hypertension as main disease, median dialysis time 54.6±8.32 months, Group 2: 63±6 years, 3 males, 2 women, main disease in one was PCKD, in other four hypertension, median dialysis time 53.6±17.98months). Our patients didn’t differ statistically in basic examined laboratory parameters on the beginning of examination (mean urea 21.38±2.15 vs. 27.44±3.93 mmol/ (p&gt;0.05), mean creatinine 936±88.5 vs. 927.6±98.8µmol/L, mean albumin 40±2.54 vs 39.8±2.77g/L (p&gt;0.05), mean calcium 2,24±0.16 vs 2.21±0.17mmol/L (p&gt;0.05), mean phosphorus level 1,84±0.39 vs 1.67±0.56mmol/L (p&gt;0.05), mean parathyroid hormone level 266.16±279.64 vs 236.14±43.99pg/mL (p&gt;0.05), and mean hemoglobin 122.2±5.72 vs 106.4±8.62g/L (p&gt;0.05). In patients on high flux haemodialysis programme there was no significant change in examined parameters during one year follow-up (for all examined parameters p value was &gt;0.05). After switching the first group on Theranova dialysers for one year there was small but statistically significant rise in urea (23.26±2.02mmol/L, p&lt;0.05), and also statistically significant decrease in serum creatinine level (840.2±75.34µmol/L, p&lt;0.05) in this group, while other parameters were not statistically significant. Comparing two groups after one year follow up, there was statistically significant higher level of hemoglobin in the first group (112.2±7.46 vs. 102g/L ±4.47, p&lt;0.05), and statistically significant decrease of beta-2 microglobuline (27.41±2.58 vs. 33.82± 2.47ng/mL, p&lt;0.05) and hepcidin (75.64±32.2 vs 100.26±10.58ng/mL, p&lt;0.05), while other parameters didn’t show statistical significance. Conclusion Our results implicate better clearance of middle weight molecules (B2M, hepcidin) in patients treated with Theranova 500 tm membrane, which could suggest anti-inflammatory effect of medium cut-off membranes, additionaly with the higher hemoglobin level after one year treatment, comparing to conventional high flux dialysis. Our results are promising, but need to be confirmed in larger randomized trials.


Sign in / Sign up

Export Citation Format

Share Document