Performance of hemodialysis with novel medium cut-off dialyzers.
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ABSTRACT: Background
Compared to high-flux dialysis membranes, novel medium cut-off (MCO) membranes show greater permeability for larger middle molecules.Methods
In two prospective, open-label, controlled, randomized, crossover pilot studies, 39 prevalent hemodialysis (HD) patients were studied in four dialysis treatments as follows: study 1, three MCO prototype dialyzers (AA, BB and CC with increasing permeability) and one high-flux dialyzer in HD; and study 2, two MCO prototype dialyzers (AA and BB) in HD and high-flux dialyzers in HD and hemodiafiltration (HDF). Primary outcome was lambda free light chain (λFLC) overall clearance. Secondary outcomes included overall clearances and pre-to-post-reduction ratios of middle and small molecules, and safety of MCO HD treatments.Results
MCO HD provided greater λFLC overall clearance [least square mean (standard error)] as follows: study 1: MCO AA 8.5 (0.54), MCO BB 11.3 (0.51), MCO CC 15.0 (0.53) versus high-flux HD 3.6 (0.51) mL/min; study 2: MCO AA 10.0 (0.58), MCO BB 12.5 (0.57) versus high-flux HD 4.4 (0.57) and HDF 6.2 (0.58) mL/min. Differences between MCO and high-flux dialyzers were consistently significant in mixed model analysis (each P < 0.001). Reduction ratios of λFLC were greater for MCO. Clearances of α1-microglobulin, complement factor D, kappa FLC (κFLC) and myoglobin were generally greater with MCO than with high-flux HD and similar to or greater than clearances with HDF. Albumin loss was moderate with MCO, but greater than with high-flux HD and HDF.Conclusions
MCO HD removes a wide range of middle molecules more effectively than high-flux HD and even exceeds the performance of high-volume HDF for large solutes, particularly λFLC.
SUBMITTER: Kirsch AH
PROVIDER: S-EPMC5837492 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:Inflammaging is a persistent, low-grade, sterile, nonresolving inflammatory state, associated with the senescence of the immune system. Such condition downregulates both innate and adaptive immune responses during chronic disorders as type II diabetes, cancer and hemodialysis, accounting for their susceptibility to infections, malignancy and resistance to vaccination. Aim of this study was to investigate hemodialysis inflammaging, by evaluating changes of several hemodialysis treatments on indoleamine 2,3-dioxygenase-1 activity and nitric oxide formation. METHODS:We conducted a randomized controlled observational crossover trial. Eighteen hemodialysis patients were treated with 3 different hemodialysis procedures respectively: 1) Low-flux bicarbonate hemodialysis, 2) Low-flux bicarbonate hemodialysis with vitamin E?-?loaded dialyzers, and 3) Hemodialfitration. The control group consisted of 14 hospital staff healthy volunteers. Blood samples were collected from all 18 hemodialysis patients just after the long interdialytic interval, at the end of each hemodialysis treatment period. RESULTS:Hemodialysis kynurenine and kynurenine/L?-?tryptophan blood ratio levels were significantly higher, when compared to the control group, indicating an increased indoleamine 2,3-dioxygenase-1 activity in hemodialysis patients. At the end of the low-flux bicarbonate hemodialysis with vitamin E?-?loaded dialyzers period, L?-?tryptophan serum levels remained unchanged vs both low-flux bicarbonate hemodialysis and hemodialfitration. Kynurenine levels instead decreased, resulting in a significant reduction of kynurenine/L?-?tryptophan blood ratio and indoleamine 2,3-dioxygenase-1 activity, when matched to both low-flux bicarbonate hemodialysis and HDF respectively. Serum nitric oxide control group levels, were significantly lower when compared to all hemodialysis patient groups. Interestingly, low-flux bicarbonate hemodialysis with vitamin E?-?loaded dialyzers nitric oxide serum levels from venous line blood samples taken 60?min after starting the hemodialysis session were significantly lower vs serum taken simultaneously from the arterial blood line. CONCLUSIONS:The treatment with more biocompatible hemodialysis procedure as low-flux bicarbonate hemodialysis with vitamin E?-?loaded dialyzers, reduced indoleamine 2,3-dioxygenase-1 activity and nitric oxide formation when compared to both low-flux bicarbonate hemodialysis and hemodialfitration. These data suggest that low-flux bicarbonate hemodialysis with vitamin E?-?loaded dialyzers lowering hemodialysis inflammaging, could be associated to changes of proinflammatory signalling a regulated molecular level. TRIAL REGISTRATION:NCT Number: NCT02981992; Other Study ID Numbers: 20100014090. First submitted: November 26, 2016. First posted: December 5, 2016. Last Update Posted: December 5, 2016.
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Project description:This study compared the therapeutic effects of medium cut-off (MCO) and high flux (HF) dialyzers using metabolomics and proteomics. This was a single-center prospective trial of 20 patients receiving maintenance hemodialysis (HD). A consecutive dialyzer membrane was used for 15-week study periods as follows: 1st HF dialyzer, MCO dialyzer, 2nd HF dialyzer, for 5 weeks respectively. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis was used to identify proteins.
2021-11-03 | PXD026907 | Pride
Project description:BackgroundA novel medium cut-off (MCO) dialyzer (Theranova, Baxter Healthcare, Deerfield, IL, USA) enhances large middle molecule clearance while retaining selectivity for molecules >45 000 Da.ObjectiveWe undertook a systematic review and meta-analysis evaluating clinical outcomes with MCO vs high-flux membranes.MethodsWe searched MEDLINE, EMBASE, CINAHL, Cochrane Library, and Web of Science through July 2020, and gray literature sources from 2017. We included randomized (RS) and nonrandomized studies (NRS) comparing MCO and high-flux membranes in adults receiving maintenance hemodialysis. Pairs of reviewers performed study selection, data extraction, and risk of bias assessment in duplicate. We conducted random-effects pairwise meta-analyses to pool results across studies and used the Grading of Recommendations Assessment, Development and Evaluation approach to assess evidence certainty.ResultsWe identified 22 eligible studies (6 RS, 16 NRS; N = 1811 patients; patient-years = 1546). The MCO dialyzer improved (estimate; 95% confidence interval [CI]; certainty rating) quality of life (mean difference [MD] = 16.7/100 points; 6.9 to 26.4; moderate), Kidney Disease Quality of Life Instrument (KDQOL) subscales-burden (MD = 4.0; 1.1 to 6.9; moderate) and effects (MD = 5.4; 3.2 to 7.6; moderate), pruritus (MD = -4.4; -7.1 to -1.7; moderate), recovery time (MD = -420 minutes; -541 to -299; high), and restless legs syndrome (odds ratio = 0.39; 0.29 to 0.53; moderate). There was little to no difference in all-cause mortality (risk difference = -0.4%; -2.8 to 2.1; moderate) and serious adverse events (rate ratio = 0.63; 0.38 to 1.04; low). MCO dialysis reduced hospitalization (rate ratio = 0.48; 0.27 to 0.84; low), infection (rate ratio = 0.38; 0.17 to 0.85; moderate), hospitalization days (MD = -1.5 days; 95% CI, -2.22 to -0.78; moderate), erythropoiesis resistance index (MD = -2.92 U/kg/week/g/L; 95% CI, -4.25 to -1.6; moderate) and cumulative iron use over 12 weeks (MD = -293 mg; 95% CI, -368 to -218; moderate). We found with low certainty that MCO dialysis had little to no effect on KDQOL symptoms/problem list, pain, and physical health and moderate certainty that MCO dialysis likely has no effect on the KDQOL mental health composite.ConclusionsWe found with predominantly moderate certainty that the MCO dialyzer improves several patient-important outcomes with no apparent risks or harms. More definitive studies are needed to better quantify the effects of MCO membranes on mortality, hospitalization, and other rare events.
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Project description:BackgroundMedium cut-off (MCO) membranes enhance large middle-molecule clearance while selectively retaining molecules >45 000 Da.ObjectivesWe undertook a systematic review and meta-analysis comparing the effects of MCO versus high-flux membranes on biomarkers.MethodsWe searched MEDLINE, Embase, CINAHL, Cochrane Library, and Web of Science from January 2015 to July 2020, and gray literature sources from 2017. We included randomized (RS) and nonrandomized studies (NRS) comparing MCO and high-flux membranes in adults (>18 years) receiving maintenance hemodialysis. We performed study selection, data extraction, and quality appraisals in duplicate and used the Grading of Recommendations Assessment, Development, and Evaluation framework. Outcomes included solute removal (plasma clearance or dialysate quantitation), reduction ratios, and predialysis serum concentrations for a range of prespecified large middle molecules.ResultsWe identified 26 eligible studies (10 RS and 16 NRS; N = 1883 patients; patient-years = 1366.3). The mean difference (MD) for albumin removal was 2.31 g per session (95% confidence interval [CI], 2.79 to 1.83; high certainty), with a reduction in predialysis albumin of -0.12 g/dl (95% CI, -0.16 to -0.07; I 2 = 0%; high certainty) in the first 24 weeks, returning to normal (MD = -0.02 g/dl, 95% CI, -0.07 to -0.03; I 2 = 56%; high certainty) after 24 weeks. We also found with high certainty that MCO dialysis resulted in a large increase (standardized mean difference [SMD]> 2.0 for all) in β2-microglobulin, κ- and λ-free light chains, and myoglobin removal, resulting in moderate (SMD > 0.5) to large (SMD > 0.8) reductions in predialysis concentrations for all of these solutes. Medium cut-off dialysis increased the reduction ratio for tumor necrosis factor-alpha (TNF-α) by 7.7% (95% CI, 4.7 to 10.6; moderate certainty), and reduced predialysis TNF-α by SMD -0.48 (95% CI, -0.91 to -0.04; moderate certainty). We found with moderate certainty that MCO dialysis had little to no effect on predialysis interleukin-6 (IL-6) plasma concentrations. Medium cut-off dialysis reduced mRNA expression of TNF-α and IL-6 in peripheral leukocytes by MD -15% (95% CI, -19.6 to -10.4; moderate certainty) and -8.8% (95% CI, -10.2 to -7.4; moderate certainty), respectively.ConclusionMedium cut-off dialysis increases the clearance of a wide range of large middle molecules and likely reduces inflammatory mediators with a concomitant transient reduction in serum albumin concentration. The net effect of MCO dialysis on large middle molecules could translate into important clinical effects.
| S-EPMC8777328 | biostudies-literature
Project description:Rationale & objectiveCurrent hemodialysis (HD) treatments have limited ability to clear larger-molecular-weight uremic toxins. Retention is associated with increased symptom burden, low health-related quality of life (HRQoL), and high mortality. Improved clearance, using novel medium cut-off dialyzers, termed expanded HD (HDx), may be associated with improved subjective experience. We have previously developed a dynamic patient-reported outcome measure (PROM) instrument to allow iterative recording to better appreciate the overall burden of disease and assess the impact of therapy changes.Study designSingle-center interventional pilot study.Setting & participants28 patients established on maintenance HD, London, Ontario, Canada.InterventionInitial study consisting of 2-week observation (baseline-conventional high-flux HD) followed by 12 weeks of HDx. HRQoL was assessed using the dynamic PROM instrument thrice weekly (enabled in a dedicated app as the London Evaluation of Illness [LEVIL]). Extension phase; 2-week baseline with 24 weeks of HDx and 8-week washout.OutcomesPrincipal aim was to establish whether HDx therapy was associated with improved HRQoL, evidence of dose-dependant response, and whether effects were durable over time, using LEVIL.ResultsPatients with lower LEVIL scores (<70/100) at baseline showed improvement in overall HRQoL after 8 weeks of therapy with similar carryover effect. General well-being, energy, and sleep quality were improved significantly as a consequence of HDx therapy. There were no detrimental effects of HDx detected in patients with higher baseline HRQoL.LimitationsSmall nonrandomized sample size. The coronavirus disease 2019 pandemic interfered with the extension phase.ConclusionsDynamic PROM assessment effectively identified patients with lower HRQoL and higher symptom burden, demonstrating durable time/dose-dependent improvements across a range of symptom domains. The use of this instrument may allow targeted selection of patients most likely to benefit from HDx therapy and assist in monitoring response and defining effect size and treatment duration to allow optimal design of further definitive randomized controlled trials of this newly introduced technology.FundingBaxter Healthcare Canada.Trial registrationClinicalTrials.gov ID: NCT03640858.
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Project description:There is little research on factors that influence the choice of dialyzer in patients undergoing hemodialysis. In patients at risk for poorer outcomes, including those with hypoalbuminemia, understanding how this choice impacts clinical parameters could inform patient management. The objective of this real-world analysis was to evaluate the use and performance of four single-use (i.e., nonreuse [NR]), high-flux Optiflux dialyzers with varying surface areas (F160NR [1.5 m2], F180NR [1.7 m2], F200NR [1.9 m2], and F250NR [2.5 m2]) in patients (N = 271) with baseline hypoalbuminemia (≤3.5 g/dl) receiving hemodialysis at a medium-sized dialysis organization. Thrice weekly, in-center dialysis was delivered for 6 months without adjustments to the hemodialysis prescription. Larger dialyzers were more frequently used in men, patients with higher body mass indices, and those with diabetes. Increases in serum albumin from baseline (month 1) to month 6 (p < 0.05) were observed with all dialyzer sizes. A mean increase in hemoglobin of 0.31 g/dl was also observed (p < 0.001). Among patients exhibiting increased serum albumin levels (n = 177), reductions in the neutrophil-to-lymphocyte ratio, a marker of inflammation, were observed (mean: 0.90; p < 0.001). These results support the use of high-flux dialyzers in patients with hypoalbuminemia.
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Project description:IntroductionSystemic anticoagulation is widely used in routine clinical hemodialysis, but can be contraindicated in specific settings. Anticoagulant-free treatment regimens are prone to failure even in chronic intermittent hemodialysis. We quantified fiber blocking in settings of reduced anticoagulation to assess performance of different dialyzers and the potential benefit of albumin priming.MethodsThis crossover study included 10 patients performing 4 hours of hemodialysis at midweek in 7 different settings: that is, using Solacea 19H and FX800, both with regular and half dose of anticoagulation, Evodial 1.3 without systemic anticoagulation, and FX800 (half dose) and Evodial (no anticoagulation) when primed with a human albumin solution. Dialyzer fiber blocking was visualized in the dialyzer outlet potting using a 3-dimensional computed tomography (CT) scanning technique on micrometer resolution.ResultsNo sessions had to be prematurely interrupted because of circuit clotting. The relative number of open fibers post dialysis was not influenced by the reduction of anticoagulation in the Solacea making this dialyzer superior in fiber patency in this setting above both the FX800 with reduced anticoagulation and the Evodial with no anticoagulation. Furthermore, no differences in relative number of open fibers were found in the FX800 and Evodial dialyzers with versus without albumin priming.ConclusionIn situations in which reduced anticoagulation is indicated, the asymmetric triacetate ATA Solacea dialyzer outperforms a dialyzer with a conventional polysulfone membrane (FX800) or with the heparin-coated polyacrylonitrile membrane (Evodial). The use of human albumin to prime the dialysis circuit did not improve dialyzer patency.
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