Search

Citrate dialysate (CD) has been successfully used in conventional hemodialysis and continuous renal replacement therapy; however, no study has compared pre- and post-dilution online hemodiafiltration (oL-HDF). Therefore, we aimed to investigate the efficacy of citrate anticoagulation for oL-HDF and the metabolic changes and quality of life of patients on hemodialysis treated using both modes Eight dialysis patients were treated with CD containing 0.8 mmol of citric acid for 4 weeks in each phase. Visual clotting scores were investigated as the primary endpoints. Adequacy of dialysis, laboratory parameters, and quality of life were measured as secondary objectives. The mean clotting scores in the pre-dilution mode were significantly lower than those in the post-dilution mode and in all phases except the heparin-free phase (p < 0.001 in the baseline phase, p = 0.001 in phase 1, and p = 0.023 in phase 2). The values of Kt/V in both modalities were comparable except during the baseline phase, in which the values of pre-dilution were significantly greater than post-dilution (2.36 ± 0.52/week vs. 1.87 ± 0.33/week;95% CI −0.81 to −0.19, p = 0.002). The patient's quality of life regarding their physical activity level was significantly higher in the post-dilution mode than in the pre-dilution mode at baseline and in phase 1 (p = 0.014 and 0.004 at baseline and in phase 1, respectively). Metabolic changes did not differ between the two modes. Citrate dialysate decreased or prevented anticoagulation in both pre- and post-dilution modes of oL-HDF without significant side effects and had comparable adequacy of dialysis. [ABSTRACT FROM AUTHOR]

Background/Objectives: The cost resulting from peritoneal dialysis (PD), conventional hemodialysis (HD) and online hemodiafiltration (OL-HDF) in pediatric patients with end-stage renal disease (ESRD) has not been estimated to date in Greece. The present single-center retrospective study aimed to estimate the mean annual cost of the above methods, as well as the individual components of this cost. Methods: Twenty pediatric patients undergoing the three different methods of renal replacement therapy were included in this study. Their mean total annual cost was estimated by the method of micro-costing and the bottom-up approach. Results: The mean total annual cost for PD patients (n = 7) was estimated at EUR 56,676.04; for conventional HD patients (n = 9), it was EUR 39,786.86; and for OL-HDF patients (n = 4), it was EUR 43,894.73. The PD method was found to be more expensive than the other two methods (p < 0.001 vs. conventional HD and p = 0.024 vs. OL-HDF). PD consumables used for daily application had the greatest contribution to the total annual cost. The total mean annual cost in the groups of patients undergoing HD and OL-HDF did not differ significantly (p = 0.175). The total operating cost of the renal dialysis unit had the greatest contribution to the total mean annual costs of both the conventional HD and OL-HDF techniques. Conclusions: This cost analysis provides useful information to healthcare policymakers who make decisions about the treatment of children with ESRD. [ABSTRACT FROM AUTHOR]

Abstract It has been reported that survival on mild hypoalbuminemia due to high albumin leakage did not worsen in patients on hemodialysis (HD) or online hemodiafiltration (OHDF) even though the level of serum albumin is a classic nutrition marker associated with mortality. Survival was also equivalent on HD and OHDF for patients with similar levels of albumin leakage and serum albumin. Furthermore, survival on HD using a super high-flux (SHF) albumin-leaking membrane was better than that on HD using a SHF membrane, and survival on SHF albumin-leaking HD with high albumin leakage was better than that on OHDF with low albumin leakage. The following hypothesis regarding crosstalk between α1-microglobulin (α1MG) and albumin is proposed that can explain the mechanism by which the level of serum human mercaptoalbumin (HMA) increases postdialysis and decreases predialysis. At initiation of and during dialysis, the production of free α1MG in the liver increases by upregulation of the α1MG-bikunin precursor gene. The free α1MG rapidly reacts with some substances that are reversibly bound to human nonmercaptoalbumin (HNA)-1, resulting in the conversion to HMA and free α1MG with reduced activity (i.e., free α1MG with reduced or no antioxidant capacity) during dialysis and in the increased serum HMA level postdialysis. In addition, it is possible that both hypoalbuminemia and the conversion of HNA-1 to HMA increase the free form of indoxyl sulfate, which is removed by diffusion. The antioxidant capacity in serum after dialysis is mainly due to the very large amount of HMA, resulting in the conversion to HNA and the decreased serum HMA level before dialysis. However, the very small amount of free α1MG produced in the liver has strong antioxidant activity after dialysis.

Background: Online hemodiafiltration (OHDF) has a lower mortality rate than hemodialysis (HD). We aimed to investigate the impact of the albumin leakage on the mortality of patients receiving HD or OHDF. Methods: In this single-center study, consecutive patients receiving renal replacement therapy between January and April 2018 were retrospectively registered. Using (1:1) propensity score matching, 3-year all-cause mortality was compared between patients receiving HD and OHDF, and the impact of albumin leakage on the mortality rate in both groups was investigated. Results: Of the 460 patients, 137 patients receiving HD were matched with an equal number of patients receiving OHDF. OHDF was associated with higher albumin leakage (p < 0.001) and a lower mortality than HD (log-rank test, p < 0.001). Albumin leakage was associated with mortality in patients receiving HD (per 1 g increase, hazard ratio (HR): 0.495, 95% confidence interval (CI): 0.275–0.888) and patients receiving OHDF (per 1 g increase, HR: 0.734, 95% CI: 0.588–0.915). Patients receiving HD, with the highest albumin leakage tertile (>3 g), had a similar mortality rate to patients receiving OHDF, with similar albumin leakage. Conclusions: The negative relationship between albumin leakage and mortality suggests the benefit of removing middle- to -large-molecular-weight substances to improve survival. [ABSTRACT FROM AUTHOR]

Online hemodiafiltration (OL-HDF) is a treatment modality using diffusion and ultrafiltration. There are two types of dilution methods in OL-HDF: pre-dilution, which is commonly provided in Japan, and post-dilution, which is commonly provided in Europe. The optimal OL-HDF method for individual patients is not well studied. In this study, we compared the clinical symptoms, laboratory data, spent dialysate, and adverse events of pre- and post-dilution OL-HDF. We conducted a prospective study of 20 patients who underwent OL-HDF between January 1, 2019 and October 30, 2019. Their clinical symptoms and dialysis efficacy were evaluated. All patients underwent OL-HDF every 3 months in the following sequence: first pre-dilution, post-dilution, and second pre-dilution. We evaluated 18 patients for the clinical study and 6 for the spent dialysate study. No significant differences in spent dialysates regarding small and large solutes, blood pressure, recovery time, and clinical symptoms were observed between the pre- and post-dilution methods. However, the serum α1-microglobulin level in post-dilution OL-HDF was lower than that in pre-dilution OL-HDF (first pre-dilution: 124.8 ± 14.3 mg/L; post-dilution: 116.6 ± 13.9 mg/L; second pre-dilution: 125.8 ± 13.0 mg/L; first pre-dilution vs. post-dilution, post-dilution vs. second pre-dilution, and first pre-dilution vs. second pre-dilution: p = 0.001, p < 0.001, and p = 1.000, respectively). The most common adverse event was an increase in transmembrane pressure in the post-dilution period. Compared to pre-dilution, the post-dilution method decreased the α1-microglobulin level; however, there were no significant differences in clinical symptoms or laboratory data. [ABSTRACT FROM AUTHOR]

Abstract Background Hemodialysis-associated pruritus (HAP) occurs in 60–80% of hemodialysis patients. This significant complication not only decreases quality of life through sleep disturbance and depression, but also leads to poor survival outcomes. The polymethylmethacrylate (PMMA) membrane was the first synthetic polymer membrane for the hollow-fiber artificial kidney created in 1977. PMMA membrane dialyzers have been reported to be effective for improving various complaints, including pruritus, and nutritional status. In Japan, a PMMA membrane hemodiafilter Filtryzer® PMF™-A (PMF-A) was launched in November 2021 and subsequently became available for online hemodiafiltration (OHDF). This study aimed to determine whether PMF-A effectively improves pruritus in hemodialysis patients. Methods Participants were 20 patients (median age 74.5 years) on predilution OHDF (pre-OHDF) or postdilution OHDF (post-OHDF) using an Asymmetric Triacetate Membrane® hemodiafilter (FIX-210E eco or FIX-210S eco), who were experiencing pruritus of “very mild” or higher severity based on the Shiratori severity score either during the daytime or nighttime. After switching to post-OHDF with PMF-21A (substitution flow rate: 10 L/session), the substitution flow rate was gradually increased according to results of pruritus evaluation every 2 weeks over 3 months. The primary endpoint was the severity of pruritus evaluated using visual analogue scale (VAS) and the Shiratori severity score. Secondary endpoints included white blood cell count (WBC), hemoglobin level (Hb), platelet count (Plt), serum albumin level (Alb), high-sensitivity C-reactive protein (hsCRP), IL-6, dry weight (DW), and solute removal performance. Results The median VAS score was significantly decreased 2 weeks after switching compared with baseline (44 mm) and remained significantly decreased at Week 12 (22 mm; p

Abstract Background Survival is equivalent between super high-flux hemodialysis (SHF-HD) and online hemodiafiltration (OHDF) with similar albumin leakage. According to the 2013 Japanese dialyzer performance classification, survival on HD is optimal when a type II dialyzer (β2-microglobulin clearance ≥ 70 mL/min) is used. Here, we investigated whether survival could be improved by SHF-HD using a type II-b dialyzer (sieving coefficient for albumin ≥ 0.03) with high albumin leakage compared with OHDF or SHF-HD using a type II-a dialyzer (sieving coefficient for albumin

ABSTRACT The CONVINCE study, recently published in the New England Journal of Medicine, reveals a groundbreaking 23% reduction in the relative risk of all-cause mortality among end-stage kidney patients undergoing high convective volume hemodiafiltration. This significant finding challenges the conventional use of high-flux hemodialysis and offers hope for improving outcomes in chronic kidney disease patients. While some controversies surround the study’s findings, including concerns about generalizability and the causes of death, it is essential to acknowledge the study’s design and its main outcomes. The CONVINCE study, part of the HORIZON 2020 project, enrolled 1360 patients and demonstrated the superiority of hemodiafiltration in reducing all-cause mortality overall, as well as in specific patient subgroups (elderly, short vintage, non-diabetic, and those without cardiac issues). Interestingly, it was shown that hemodiafiltration had a protective effect against infection, including COVID-19. Future research will address sustainability, dose scaling effects, identification of subgroups especially likely to benefit and cost-effectiveness. However, for now, the findings strongly support a broader adoption of hemodiafiltration in renal replacement therapy, marking a significant advancement in the field.

Online hemodiafiltration (OHDF) for renal replacement therapy has two modes: pre- (pre-OHDF) and post-dilution OHDF (post-OHDF). To elucidate the precise differences between the two modes, a clinical study was performed using the same polysulfone hemodiafilters in the same patients. Eight patients were treated with ABH™-22PA for 6 weeks: 3 weeks of pre-OHDF (with substitution volumes of 24, 36, and 48 L) and 3 weeks of post-OHDF (6, 8, and 10 L). The reduction ratios of urea, uric acid (UA), creatinine (CRE), inorganic phosphorus (iP), beta-2-microglobulin (β2-MG), and alpha-1-microglobulin (α1-MG) were evaluated. The removal amounts of β2-MG, α1-MG, and albumin were also evaluated by analyzing the spent dialysis fluids. The types and numbers of adverse events (AEs) and device malfunctions were recorded. The reduction ratios of urea, UA, CRE, iP, and β2-MG were comparable among all conditions, while that of α1-MG tended to be slightly higher in post-OHDF than in pre-OHDF. The removal amounts of α1-MG and albumin in pre-OHDF and post-OHDF were significantly greater with the maximum substitution volume than with the minimum volume. However, the selective removal indices, which were obtained by dividing the amount of α1-MG removed by the albumin level, tended to be slightly higher in pre- than in post-OHDF. No device-related AEs or device malfunctions occurred in either mode. No significant differences in inflammatory responses, evaluated by high-sensitivity C-reactive protein and interleukin-6, were observed. This study provides removal performance and safety data regarding the application of ABH-22PA for pre- and post-OHDF. [ABSTRACT FROM AUTHOR]

Introduction: Expanded hemodialysis (HDx) is expected to provide enhanced permeability of medium-sized molecules, selective solute retention, and better internal retrofiltration. The primary objective of this study was to compare the efficiency for removal of β2-microglobulin with 3 different extracorporeal therapies (ETs): high-flux hemodialysis (HF), online hemodiafiltration (OL-HDF), and HDx. The secondary objective was to evaluate the efficiency of removal of other uremic toxins, including urea, phosphate, CRP, IL-6, IL-10, TNF-⍺, indoxyl sulfate, and p-cresol. Methods: This single-center, randomized, and cross-over study was performed. Patients were randomized to determine the initial modality of treatment, each period lasted 4 weeks and between one modality and another, there was a washout period of 1 week. Reduction ratios (RRs) of different-size molecules and albumin were calculated for the different ET. Results: Twenty-two patients were included, β2-microglobulin RR was greater during both OL-HDF and HDx as compared to HF (RR 62% vs. 73% vs. 27%, respectively, p = <0.0001), and there was no significant difference between HDx and OL-HDF (p = 0.09). A decrease in serum phosphate levels was observed in the HDx and OL-HDF periods, contrary to an increase in HF (−0.79 mg/dL vs. −1.02 mg/dL vs. + 0.11 mg/dL, respectively, p = <0.0001). There was no difference in RRs of other molecules (BUN, CRP, IL-6, IL-10, TNF-⍺, indoxyl sulfate, and p-Cresol). There was no decrease in serum albumin in any ET. Conclusion: HDx provides enhanced removal of β2-microglobulin and phosphate as compared to HF, and similar efficacy as with OL-HDF. HDx should be considered an alternative to chronic convective therapies. [ABSTRACT FROM AUTHOR]

Abstract Background All-cause mortality is lower with a high substitution volume in predilution (pre) and postdilution (post) online hemodiafiltration (OHDF) than with hemodialysis (HD), and mortality does not significantly differ between pre- and post-OHDF groups. Despite the improved survival with a high substitution volume, there may be limitations. On the other hand, either normoalbuminemia or high albumin leakage in HD can reduce mortality, and super high-flux (SHF) membrane dialyzers can reduce mortality compared with low-flux and high-flux membrane dialyzers. Here, we investigated the associations of serum albumin concentration (s-Alb), albumin leakage, and substitution volume with all-cause mortality in OHDF and SHF-HD. Methods In a 3-year retrospective observational study of patients receiving dialysis from April 1 to July 1, 2017, we developed a propensity score-matched model using 783 stable patients (SHF-HD, 355; OHDF, 428). We used the log-rank test to compare Kaplan–Meier survival curves and Cox regression analysis to calculate hazard ratio (HR). Cox regression analysis was also used to compare the effect of estimated albumin leakage (EAL) and substitution volume on 3-year all-cause mortality. Results All-cause mortality was significantly lower with high EAL than with low EAL (SHF-HD: P = 0.012, log-rank test; HR, 0.44; 95% confidence interval [CI] 0.23–0.85; OHDF: P = 0.027, log-rank test; HR, 0.41; 95% CI 0.18–0.93). The mortality of high EAL was not significantly different between high and low s-Alb in SHF-HD (3.5 ± 0.1 and 3.2 ± 0.2 g/dL) and OHDF (3.6 ± 0.2 and 3.2 ± 0.1 g/dL), despite significant differences in s-Alb. Mortality did not significantly differ between SHF-HD and OHDF with higher EAL ranges or a lower difference in EAL. Mortality in pre-OHDF was significantly correlated with EAL (P = 0.007, beta − 0.32) rather than substitution volume, and mortality in post-OHDF was not analyzed because of fewer deaths. Conclusions The results suggest that survival is improved more with high EAL than with low EAL in both OHDF and SHF-HD patients, that high EAL with mild-to-moderate hypoalbuminemia does not necessarily worsen survival in OHDF and SHF-HD patients, and that survival is equivalent between OHDF and SHF-HD patients with a similar level of EAL.

Abstract Background A fluid commonly used for dialysis in Japan is prepared from two dialysate concentrates and dialysis water. Silicon (Si) from tap water is reported in dialysis water as suspended insoluble particulate matters. We aimed to examine the source of insoluble particulate matters in the online prepared substitution fluid and to examine effects of the silica (SiO2) of tap water on the SiO2 of dialysis water. Method Based on the number of particles and particle size distribution in online prepared substitution fluid, we evaluated particle diameters and constituent elements of particles in online prepared substitution fluid. To identify sources of insoluble particulate matters in the online prepared substitution fluid, we measured particle diameters and constituent elements of particles adhering to the surface of hollow fiber of the final endotoxin-retentive filter (ETRF) and to the inner surface of the housing of the final ETRF and measured SiO2 in tap water, dialysis water, and commercial sterile substitution fluid. Results Si-containing particles accounted for 83% of 30 particles detected in the final ETRF (the hollow fibers and the housing) and the online prepared substitution fluid sampled from the final ETRF. The large variability in the SiO2 in tap water depending on the geographic regions. The SiO2 in dialysis water was 0.4–0.7 mg/L. Si was not detected in particles in the commercial sterilized substitution fluid, and the commercial sterile substitution fluids contained SiO2 at 0.1 mg/L. Conclusion We presume that insoluble particulates in online prepared substitution fluid were calcium and magnesium precipitated from dialysate and Si precipitated from dialysis water. Moreover, variation in the SiO2 in tap water is a factor affecting the SiO2 level in dialysis water. If the formation of silicates in the online prepared substitution fluid is considered and the target SiO2 in dialysis water is to be set ≤ 0.1 mg/L, SiO2 in tap water available in hospitals and dialysis centers should be known before specifications of instruments for dialysis fluid preparation are determined.

Introduction: The present cross‐sectional study aimed to compare the prevalence, the characteristics of post‐dialysis fatigue and the length of recovery time after hemodialysis in prevalent end‐stage renal disease patients (ESRD) receiving bicarbonate hemodialysis (HD) or hemodiafiltration (HDF). Methods: Patients were suffering from post‐dialysis fatigue if they spontaneously offered this complaint when asked the open‐ended question: "Do you feel fatigued after dialysis?". Moreover, each patient was invited to rate the intensity, duration, and frequency of post‐dialysis fatigue from 1 to 5. In order to assess RECOVERY TIME AFTER DIALYSIS, patients were invited to answer to the following single open‐ended question: "How long does it take you to recover from a dialysis session?" Findings: We included 335 patients: 252 received HD and 83 received HDF. Post‐dialysis fatigue was present in 204 patients (60.9%). Prevalence of post‐dialysis fatigue did not differ significantly between patients on HD (62.3%) and on HDF (56.6%; p = 0.430). Median recovery time after dialysis was 180 min [180–240] and did not differ significantly between the two subgroups (180 min [130–240] and 240 min [120–332] p = 0.671, respectively). Median post‐dialysis fatigue intensity, duration, and frequency were 3 [1–5], 3 [1–5], and 4 [1–5] and did not differ significantly between patients on HD and on HDF. At the multivariate analysis, age, ADL and hemoglobin levels were the independent predictors of the HDF treatment. Discussion: Prevalence and characteristics of post‐dialysis fatigue do not differ significantly between patients receiving bicarbonate HD or HDF. [ABSTRACT FROM AUTHOR]

Introduction: There is no standard for insoluble particulate matters in dialysate. We evaluated the insoluble particulate matters in online prepared substitution fluid. Methods: We evaluated particle diameters and constituent elements of particles in online prepared substitution fluid and the final endotoxin retentive filter (ETRF). Results: The measurement results with particles in the online prepared substitution fluid and particles attached to the final ETRF revealed that Ca‐containing particles accounted for 11 particles and Si‐containing particles accounted for 19 particles of 30 particles detected in the online prepared substitution fluid and the final ETRF. Conclusion: We presume that insoluble particulates in online prepared substitution fluid were Ca and Mg precipitated from dialysate and Si precipitated from dialysis water. Even if two ETRFs were connected in series, these particles were formed in the final ETRF. [ABSTRACT FROM AUTHOR]

Background: Determining the optimal dialysate sodium remains one of the challenges of hemodialysis prescription. Several arguments suggest that the dialysate sodium should be individually adjusted according to the patient's natremia. This strategy is greatly facilitated by using an algorithm. Only three such algorithms have been embedded in hemodialysis machines for the widespread generalization of this strategy in clinical routine: the Diacontrol (Hospal‐Baxter Healthcare Corp., Deerfield, IL, USA), the HFR‐Aequilibrium (Bellco‐Medtronic, Dublin, Ireland), and the Na‐control (Fresenius Medical Care, Bad‐Homburg, Germany). Methods: Model the solute mass‐transfer across the dialyzer membrane in online hemodiafiltration and adapt the Diacontrol algorithm based on a single‐pool kinetic model of sodium balance for quantifying ionic balance and managing tonicity. Results: (1) Substituting sodium measurements with conductivity measurements allows the control of tonicity which is a more physiological parameter than natremia. (2) Consideration of all ion exchanges as a whole and not just sodium exchange avoids some of the assumptions required by kinetic modeling of sodium balance. (3) Equations provided by the model are applicable to both hemodialysis and online hemodiafiltration. (4) The differences between this model used by Diacontrol and the models on which the other two software's (HFR‐Aequilibrium and Na‐control) are based are highlighted. Conclusions: The single‐pool kinetic model developed for the management of natremia in hemodialysis is also valid for the management of tonicity for both conventional hemodialysis and all online hemodiafiltration procedures. [ABSTRACT FROM AUTHOR]

Introduction: New dialysis membranes with new properties are being developed to improve efficacy and tolerance. The hemocompatibility of a polymeric biomaterial is influenced by the layer of water at the blood membrane interface. The new dialyzer TORAY NV-U ® has a membrane Hydrolink™, designed to suppress platelet adhesion and to improve the hemocompatibility. Until now, there is no experience in online hemodiafiltration (OL-HDF).The objective of the present study is to evaluate the efficacy of this new membrane in OL-HDF therapy compared to another membrane commonly used. Other objectives are to evaluate the inflammatory response, hemodynamic tolerance, and the anticoagulation regimes., Methods: This is a prospective pilot study performed in five anuric patients receiving OL-HDF. For 1 month patients were kept with their usual dialyzer FX1000 ® (FMC). Subsequently, the dialyzer was changed to TORAY NV-U ® (Hydrolink ® ) for 1 month. In the last dialysis session of each dialyzer, blood tests were performed to evaluate inflammation and depurative capacity., Results: We did not find differences in medium size removal molecules and convective volume: FX1000 ® : 31 ± 9 l per session and Hydrolink™ 30 ± 8 l; p  = 0.7); β2microglobulin reduction ratio (RR) FX1000 ® FMC 83 ± 3%; Hydrolink™ 79 ± 4; p  = 0.14; Myoglobin RR FX1000 ® FMC 72 ± 7%; Hydrolink™ 76 ± 4; p  = 0.28. We did not find differences in inflammation parameters: serum IL6 with FX1000 ® 6.0 ± 4.2 pg/mL; Hydrolink™ 7.6 ± 5.0 pg/mL; p  = 0.3.During all sessions with the two dialyzers there was adequate plasmatic filling, reaching 85 % filling. All patients had "good" dialyzer status in all dialysis sessions with TORAY NV-U ® , while the dialyzer status with FX1000 ® was "good" in 20% of the sessions, "medium" in 30%, and "dirty" in the remaining 50% dialysis sessions., Conclusions: The new dialyzer Hydrolink™, TORAY NV-U ® is not inferior to perform OL-HDF compared to dialyzers usually used for this therapy, and could allow decrease heparin doses. Further studies with a bigger sample size and longer follow-up will answer if Hydrolink improves inflammation and assess a better hemodynamic tolerance., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background/Aim: Supra hemodiafiltration with reinfusion of the endogenous ultrafiltrate (Supra-HFR) is a dialysis technique used to improve uremic toxin removal in the range of the middle molecular weight molecules. Supra-HFR does not require the preparation and online infusion of highpurity dialysis water because it allows the production of an endogenous ultrafiltrate that undergoes detoxification through an adsorbing resin. Patients and Methods: We investigated the ability of Supra-HFR to remove fibroblast growth factor 23 (FGF23), interleukin 6 (IL-6), tumor necrosis factor alpha (TNFalpha), interleukin 8 (IL-8), and transforming growth factor alpha (TGF-alpha) after a single session dialysis in nine patients affected by end stage renal disease (ESRD). The same patients underwent a single session of online hemodiafiltration (OLHDF) to evaluate possible differences in FGF23 and IL-6 levels. Results: A significant reduction in FGF23 was observed with both Supra-HFR (p=0.001) and OL-HDF. As for TNF-alpha and TGF-alpha, which were measured using Supra-HFR only, their percentage values were significantly lower at the end of dialysis than at the start (p=0.0028 and p=0.03, respectively). This did not change with post-dialysis rebound. Supra-HFR was found to have no effect on IL-6 and IL-8. Interestingly, the removal rate for FGF23 and IL-6 was similar to that observed with OL-HDF. Conclusion: Supra-HFR was not superior to OL-HDF, with suboptimal convective volume in the removal of the molecules tested, especially FGF23, which is considered a large middle molecular weight uremic toxin. [ABSTRACT FROM AUTHOR]

Background The use of newly developed mixed-dilution hemodiafiltration (HDF) can supplement the weaknesses of pre- and postdilution HDF. However, it is unclear whether mixed-HDF performs well compared to predilution HDF. Methods We conducted a prospective, open-labeled, randomized controlled trial from two hemodialysis centers in Korea. Between January 2017 and September 2019, 60 patients who underwent chronic hemodialysis were randomly assigned at a 1:1 ratio to receive either predilution HDF (n = 30) or mixed-HDF (n = 30) for 6 months. We compared convection volume, changes in small- and medium-sized molecule clearance, high-sensitive C-reactive protein (hs-CRP) level, and dialysis-related parameters between the two dialysis modalities. Results A mean effective convection volume of 41.0 ± 10.3 L/session in the predilution HDF group and 51.5 ± 9.0 L/session in the mixed-HDF group was obtained by averaging values of three time-points. The difference in effective convection volume between the groups was 10.5 ± 1.3 L/session. This met the preset noninferiority criteria, suggesting that mixed-HDF was noninferior to predilution HDF. Moreover, the β2-microglobulin reduction rate was greater in the mixed-HDF group than in the predilution HDF group, while mixed-HDF provided greater transmembrane pressure. There were no significant between-group differences in Kt/V urea levels, changes in predialysis hs-CRP levels, proportions of overhydration, or blood pressure values. Symptomatic intradialytic hypotension episodes and other adverse events occurred similarly in the two groups. Conclusion Use of mixed-HDF was comparable to predilution HDF in terms of delivered convection volume and clinical parameters. Moreover, mixed-HDF provided better β2-microglobulin clearance than predilution HDF.

Abstract Background Online hemodiafiltration (OL-HDF), whether in pre-dilution OL-HDF (pre-HDF) or post-dilution OL-HDF (post-HDF), is conducted to efficiently remove low molecular weight proteins from the blood of patients requiring dialysis. β2-microglobulin (β2-MG) and α1-microglobulin (α1-MG) are used as biomarkers to evaluate removal efficiency of OL-HDF. We aimed to evaluate the relationship between β2-MG and α1-MG reduction rates and the amount of albumin leakage. Furthermore, we statistically analyzed the relationship between the α1-MG reduction rate and α1-MG removal amount, and its suitability as a biomarker for evaluating the removal efficiency of OL-HDF. Methods We collected the results of regularly conducted routine evaluations to assess the efficiency of OL-HDF from cases of patients undergoing maintenance dialysis at our clinic from 2018 to 2019. Data on was collected on both pre-HDF and post-HDF sessions. β2-MG and α1-MG reduction rates were analyzed. Regression analysis on reduction rates showed a significant correlation between the α1-MG reduction rate and the α1-MG removal amount. Results We conducted 435 tests on OL-HDF efficiency in 87 cases undergoing maintenance dialysis at our clinic in 2018 and 2019. There were 80.7 ± 4.5% for the β2-MG reduction rate, 33.8 ± 9.4% for the α1-MG reduction rate, and 3.9 ± 1.8 g/s for the amount of albumin leakage. There was no correlation between the β2-MG reduction rate and the α1-MG reduction rate, or between the amount of albumin leakage and β2-MG reduction rate. Conclusion α1-MG reduction rate was found to correlate with its removal amount, demonstrating its suitability as a biomarker for evaluating the removal efficiency of OL-HDF. Trial registration Retrospectively registered.

Introduction: Acute kidney injury (AKI) after high dose methotrexate (HD-MTX) is associated with delayed MTX-excretion and life-threatening toxicity. Glucapridase, the recommended therapy, is expensive and not always available. Case series: We describe 3 cases (69, 67, 73 years) with diffuse large B-cell lymphoma who developed AKI and early-onset severely delayed MTX elimination after HD-MTX. MTX serum concentrations were 101 and 69 μmol/L at 24 h after administration in two patients and 34 μmol/L at 32 h in the third. Management and outcome: Since glucarpidase was unavailable, we performed daily high-flux hemodialysis (HF-HD) or online hemodiafiltration (HDF) sessions (median duration, 6 h). The median serum MTX elimination half-life during HDF/HF-HD sessions was similar in all patients (median, 4.4 h; IQR, 3.8–5.3 h), but serum MTX concentrations rebounded after each dialysis by a median of 40% of the trough concentrations. The three patients underwent multiple dialysis sessions, until MTX serum concentrations remained sufficiently low to be neutralized by leucovorin. Only 1 patient developed severe pancytopenia, and renal function normalized in all patients after 3–6 weeks. Discussion: In conclusion, when glucarpidase is unavailable or delayed, early, repeated and prolonged HDF/HF-HD effectively enhance MTX elimination and prevent toxicity in patients with AKI and severely delayed MTX elimination after HD-MTX. [ABSTRACT FROM AUTHOR]

Expanded hemodialysis (HDx) has a high capacity for removing medium and medium‐large molecules; however, there are no specific recommendations during HDx for anticoagulation of the dialysis circuit. We aimed to evaluate the differences in the efficacy of anticoagulation procedures using the venous port and 40 mg enoxaparin in HDx compared to high‐flux hemodialysis (HF‐HD) and postdilution online hemodiafiltration (HDF). We compared anticoagulant activity in 11 patients in HDx, HF‐HD, and HDF under similar dialysis conditions. In the 33 dialysis sessions, 40 mg enoxaparin was administered through the venous port, and pre‐ and postdialysis antifactor Xa activity (aXa) and activated partial thromboplastin time (APTT), postdialysis clotting time of the vascular access, visual clotting score of the dialyzer, and any complications with the extracorporeal circuit or bleeding were registered. APTT postdialysis in HDx was not significantly different from that in HF‐HD and HDF. Postdialysis aXa in HDx was not significantly different from that in HF‐HD and HDF. We found no significant differences in visual clotting score of the dialyzer. Enoxaparin administered through the venous port was sufficient for anticoagulation within the extracorporeal circuit in HDx, HF‐HD, and HDF. There were no differences in postdialysis aXa or APTT, most likely because when low molecular–weight heparin is applied through venous port, lesser enoxaparin concentration reaches the dialyzer. Thus, we conclude that the dose of enoxaparin administered through the venous port should not be adjusted according to dialysis technique. [ABSTRACT FROM AUTHOR]

Objective: to evaluate the dependence of the magnitude of convection flow in online hemodiafiltration (OLHDF) on ultrafiltration control method and patients’ individual characteristics. Materials and methods. The study included 36 stable dialysis patients (20 male and 16 female). The substitution rate was conducted manually based on transmembrane pressure (TMP). In some cases, devices with automatic filtration rate control unit AutoSub plus were used. The filtration rate (FR), TMP, blood flow rate (Qb), specific filtration rate (SFR, m/l/min/mm Hg–1 ) were recorded. Results. The maximum SFR in various patients ranged from 0.51 to 0.80 ml/min/mm Hg–1 ; average value was 0.62 ± 0.07 ml/min/mm Hg–1 . There was significant correlation of SFR with hemoglobin level (r = –0.55). SFR reduced during hemodiafiltration (on average – by 23 ± 4%). SFR was significantly affected by Qb (r = 0.70). Maximum SFR was achieved with a TMP of 140–220 mm Hg; with TMP over 250 mm Hg, a decrease in SFR was noted, an increase in Qb was required for further increase in FR. Individual stability of SFR was noted during serial observations; fluctuations in a particular patient did not exceed 10%. Substitution volume for the HDF session was 18.0 ± 3.3 L, the FR/Qb ratio was 24.7 ± 5.2%. Substitution volume of 21 L was not achieved in 17 of 36 patients. The use of automatic FR adjustment system made it possible to increase the substitution volume (SV) by 12–18%. Conclusion. Achieving maximum convection volume in OLHDF requires individualizing treatment parameters. The use of FR automatic control allows maximum possible convection flow.

Introduction Online hemodiafiltration (OL-HDF) is the most effective renal replacement therapy (RRT), which allows the enhanced removal of small and large uremic toxins by combining diffusion and convective transport of solutes. Although the goal of OL-HDF is to provide greater clearance of solutes with a preference for intermediate molecules responsible for many of the complications of chronic kidney disease (CKD), the studies reported to date and their meta-analyses are conflicting in nature and do not show a significant advantage of convective therapies on patient prognosis. Materials and methods At the Clinic of Nephrology and Dialysis, University Hospital "St. Marina", Varna, Bulgaria, 41 patients were monitored in a retrospective study for a two-year period, randomized into two groups, conducting OL-HDF after dilution and hemodialysis (HD) with the aim of studying the effect of convective therapies on the clinical outcome, the achieved quality of life, and the prognosis of the patient. Results The study found a significantly higher quality of life in patients undergoing OL-HDF with significantly higher values ​​of indicators of dialysis adequacy and nutritional status, better control of the anemic syndrome with the reduction of erythropoietin doses, significantly lower frequency of episodes of intradialytic hypotension with improved recovery, and 3.6-fold lower risk of death compared with conventional dialysis. Discussion Three major randomized controlled trials have compared survival outcomes in patients receiving HD or post-dilution OL-HDF, reporting conflicting results. Meta-analyses of the published studies have also been unable to provide a clear and definitive answer regarding the potential benefits of choosing one treatment over the other. Overall mortality, anemia, phosphate control, and small molecule clearance appear to be insufficiently influenced by the treatment method. On the other hand, cardiovascular mortality, hemodynamic stability, and clearance of middle and protein-bound molecules seem to be better in patients treated with OL-HDF. Conclusions Despite the conflicting data reported so far, OL-HDF is associated with better clinical outcome and prognosis for end-stage renal disease (ESRD) patient and undoubtedly warrants extensive future study with a view to improved quality of life in the growing dialysis population., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Nenova et al.)

Abstract Background Online hemodiafiltration (OL-HDF) is associated with better removal of both small and middle molecules and might improve survival compared to conventional hemodialysis (HD). Nevertheless, hemodiafiltration (HDF) can lead to an increase in albumin loss across the dialyzer, especially with high permeability membrane and high convective volume (CV). We present the case of a patient treated by OL-HDF who developed severe hypoalbuminemia resulting from massive albumin loss into dialysate. Case presentation A 71-year-old woman with ESRD started renal replacement therapy in December 2016. She was treated by high volume post-dilution OL-HDF, 4 h, 3 times per week. The dialyzer was the Phylther HF20SD (a 2.0m2 heat sterilized high flux (HF) polyphenylene membrane from Bellco). At the initiation of dialysis, the serum albumin was 4.0 g/dl. During the following months, the patient developed severe hypoalbuminemia. The lowest value observed was 2.26 g/dl in July 2017. Diagnostic workup excluded nephrotic syndrome, hepatic failure and malabsorption. The patient was shifted from OL-HDF to standard HF HD, keeping the same dialyzer and dialysis schedule. During the following months, we observed a progressive correction of the hypoalbuminemia (3.82 g/dl at last follow-up). To precise the impact of the epuration technique on the albumin losses in this patient, we measured the amount of albumin in dialysate during one session with the Phylther HF20SD on OL-HDF and one session with the same filter but on standard HD. The CV was 29.0 l for the HDF session. The total albumin losses were 23.6 g on OL-HDF and 4.6 g on HD. Conclusion OL-HDF can lead to significant albumin loss into the dialysate, especially with high permeability membrane and high CV. When prescribing post-dilutional OL-HDF, the choice of the dialyzer membrane should be made with caution. Users of the steam sterilized polyphenylene membrane, the Phylther SD, should be informed of the risk of large albumin loss with this membrane during post-dilution OL-HDF.

Hemodialysis‐related headache (HRH) is a well‐known clinical event. It is considered as one of the most commonly reported neurological symptoms among hemodialysis patients. Its epidemiological, physiological, clinical, and therapeutic data remain scarce and are poorly studied. Our aim was to determine the frequency of HRH in the region of Casablanca, Morocco, to describe its clinical characteristics and to explore the hypothesis that renal replacement techniques, such as conventional versus online hemodiafiltration may have an association on clinical adverse effects like HRH. A descriptive, cross‐sectional, and multicentric study was carried out among 100 chronic hemodialysis patients for at least 6 months. HRH was defined according to criteria published by the International Classification of Headache Disorder third edition beta version (ICHD3β) [1]. Two different HD‐modalities (standard HD and OL‐HDF) have been investigated in order to explore their impact on HRH. Headache was reported by 60% of the patients including 41.6% of hemodialysis‐related headache. HRH had on average a duration of 7.4 hours, pulsatile among 38% of interviewed patients and of moderate intensity in 48% of cases. In total, 51.3% of patients undergoing conventional hemodialysis modality reported HRH compared to 12.5% undergoing online hemodiafiltration technique (OL‐HDF) (P =.008). Hemodialysis‐related headache remains a poorly studied clinical event despite its high prevalence. Its diagnosis, management, and especially its prevention remain a challenge for the neurologist and the nephrologist. Our results suggest that OL‐HDF is a promising therapeutic and preventive tool to reduce the incidence of HRH. [ABSTRACT FROM AUTHOR]

Background: Evidence suggests that online hemodiafiltration (OL-HDF) is associated with improved survival. Whether the dose-response relationship between convective volume and mortality may be confounded by selection bias or descends from practice patterns is not clear. We sought to evaluate the role of patients' characteristics and practice patterns on OL-HDF dose and mortality in a large private dialysis network in the Republic of Russia. Methods: In this multicenter, historical cohort study, we included adult incident patients on OL-HDF with at least 90 days of survival on renal replacement therapy in centers belonging to the Russian Federation Fresenius Medical Care network (January 1, 2011, to December 31, 2016). We evaluated predictors and outcomes (survival) of substitution volume target achievement (Qsub > 21 L/session). Results: Among 1,081 enrolled patients, the average Qsub was 22.9 (±3.2) L/session; the mean ultrafiltration volume was 1.6 (±0.8) L/session. The mean age was 55.8 ± 13.2; 42% were woman. Most common comorbidities were congestive heart failure (39.7%) and peripheral vascular disease (21.7%). The average hemoglobin was 9.3 ± 1.3. The case-mix adjusted center effect accounted for 20% of variance in Qsub. The top 10 most important variables associated with higher Qsub were effective Qb, serum protein, Charlson's comorbidity index, hemoglobin, year of dialysis initiation (proxy of high Qsub treatment policy in the clinic network), predialysis heart rate, serum bicarbonate, serum phosphate, age, serum sodium, and dry body weight. In addition, we found that the association of Qb with Qsub is moderated by year of enrollment, intradialytic weight gain, and coronary artery disease, whereas higher hemoglobin concentration moderated the relationship between treatment time and Qsub. Finally, Qsub between 21 and 25 L/session was associated with longer 5-year survival. Conclusions: Both center-dependent clinical practice standards and patient clinical conditions substantially contributed to the risk of low Qsub. We confirmed previous evidence indicating better survival among patients with Qsub ≥ 21 L/session. [ABSTRACT FROM AUTHOR]

As increasing demand for hemodialysis (HD) treatment incurs significant financial burden to healthcare systems and ecological burden as well, novel therapeutic approaches as well as innovations and technological advances are being sought that could lead to the development of purification devices such as dialyzers with improved characteristics and wearable technology. Novel knowledge such as the development of more accurate kinetic models, the development of novel HD membranes with the use of nanotechnology, novel manufacturing processes, and the latest technology in the science of materials have enabled novel solutions already marketed or on the verge of becoming commercially available. This collaborative article reviews the latest advances in HD as they were presented by the authors in a recent symposium titled "Frontiers in Haemodialysis," held on 12th December 2019 at the Royal Society of Medicine in London. [ABSTRACT FROM AUTHOR]

Purpose: The mortality of dialysis patients treated with high-volume online hemodiafiltration (OL-HDF) is better than hemodialysis, but is still higher than healthy population. Low daily physical activity increases cardiovascular mortality. Addition of intradialytic exercise (IDX) program might improve physical activity and health status in OL-HDF patients. This pilot open-labeled randomized-controlled trial was conducted to evaluate the effects of IDX on physical activity and other clinical parameters in OL-HDF patients. Methods: Twelve OL-HDF patients were randomized into control (n = 6) or IDX (n = 6) groups. The subjects in IDX group were trained to exercise using a cycle ergometer for 60 min during each OL-HDF session. Physical activity measured as daily step count using a wrist-worn triaxial accelerometer, physical fitness, or cardiorespiratory fitness assessed by VO2max and other physical performance tests, lean body mass determined by the Dual-energy X-ray absorptiometry (DXA), quality of life (QOL), and various parameters were compared between baseline and 6 months. Results: The baseline physical activity status was comparable. Following 6-month IDX, the physical activity was significantly improved in IDX group [+ 1048.79 (+ 741.50, + 2792.54) vs. − 362.06 (− 1626.82, − 167.47) steps/day, p = 0.01], while physical fitness and QOL were unchanged. The lean body mass parameters were preserved in the IDX group while seemed to decrease in the control group. Serum albumin was significantly increased in the IDX group (p = 0.01). The hemoglobin changes were significantly better (p = 0.01) and the erythropoietin resistance index was significantly lower in the IDX group (p = 0.03). Phosphate reduction was significantly greater in the IDX group (p = 0.04). Conclusions: IDX could improve physical activity and other metabolic parameters in OL-HDF patients and these might contribute to further improvement in clinical and survival outcomes. Trial registration: ClinicalTrials.gov Registration: NCT03353844. [ABSTRACT FROM AUTHOR]

Although high‐volume postdilution online hemodiafiltration (ol‐HDF) is superior to high‐flux HD in removing all kinds of uremic toxins and improving survival, this treatment is not available in most HD centers. The present study was conducted to compare the effectiveness in removals of protein‐bound (indoxyl sulfate [IS]), middle‐molecule [beta‐2 microglobulin (B2M) and alpha‐1 microglobulin (A1MG)], and small‐molecule uremic toxins between super high‐flux HD (SHF‐HD), HD with a novel SHF dialyzer and high‐volume postdilution ol‐HDF in a noninferiority fashion. Fifteen prevalent HD patients were randomly allocated into two sequences of 12‐week treatment periods of SHF‐HD treatment and later high‐volume postdilution ol‐HDF period or vice versa. Each treatment period was divided by a wash‐out phase of 4‐week high‐flux HD. Twelve of 15 patients could complete the study. When compared with high‐volume postdilution ol‐HDF (convective volume of 24.4 ± 3.52 L), SHF‐HD provided comparable reduction ratio values of IS, B2M, and A1MG with mean difference of 5.87 (95% confidence interval [CI] ‐1.63, 13.37), 1.98 (95% CI,‐0.21, 4.18), and 22.96 (95% CI, ‐1.91, 47.83), respectively. The spKt/Vurea was not different. The predialysis levels of all uremic toxins at baseline and after 12‐week treatment did not differ between both groups. Although albumin loss in dialysate in SHF‐HD was greater than high‐volume postdilution ol‐HDF, the serum albumin levels after 12‐week SHF‐HD treatment were significantly higher than baseline. In conclusion, SHF‐HD provides noninferior effectiveness to high‐volume postdilution ol‐HDF in removing various uremic toxins with significantly increased serum albumin levels despite higher albumin loss. SHF‐HD might be an effectively alternative treatment when high‐volume postdilution ol‐HDF is not available. [ABSTRACT FROM AUTHOR]

Abstracts ᅟ The annual survey of Japanese Society for Dialysis Therapy Renal Data Registry (JRDR) was conducted for 4380 dialysis facilities at the end of 2015, among which 4321 facilities (98.7%) responded. The response rate of the 2015 survey was comparable with the past, even though it was the first year after the new anonymization method. The number of chronic dialysis patients in Japan continues to increase every year; it has reached 324,986 at the end of 2015. The mean age was 67.86 years. At the end of 2015, the prevalence rate was 2592 patients per million population. Diabetic nephropathy was the most common primary disease among the prevalent dialysis patients (38.4%), followed by chronic glomerulonephritis (29.8%) and nephrosclerosis (9.5%). The rate of diabetic nephropathy and nephrosclerosis has been increasing year by year, whereas that of chronic glomerulonephritis was declining. The number of incident dialysis patients during 2015 was 39,462; it has remained stable since 2008. The average age was 69.20 years, and diabetic nephropathy (43.7%) was the most common cause in the incident dialysis patients. These patients caused by diabetes did not change in number for the last several years. Meanwhile, 31,608 patients died in 2015; the crude mortality rate was 9.6%. The patients treated by hemodiafiltration (HDF) have been increasing rapidly from the revision of medical reimbursement for HDF therapy in 2012. It has attained 53,776 patients at the end of 2015, which were 10,493 greater than that in 2014. In particular, the number of online HDF patients increased about ten times 2012. The number of peritoneal dialysis (PD) patients was 9322 in 2015, which was slightly increased than 2014. Twenty percent of PD patients treated in the combination of hemodialysis (HD) or HDF therapy. Five hundred seventy-two patients underwent home HD therapy at the end of 2015; it increased by 43 from 2014. Further JRDR data analyses could clarify the relationships between various dialysis modalities, patient care, and clinical outcomes; furthermore, it could also make it possible to establish clinical practice guidelines or medical reimbursement revisions based on the evidence. Trial registration JRDR was approved by the ethical committee of JSDT and has been registered in the “University hospital Medical Information Network (UMIN) Clinical Trials Registry” as an approved number of UMIN000018641 since 2015.

Background: Hemodiafiltration (HDF) is a newly developed renal replacement therapy blood purification technology with more advantageous effects on hemodynamic stability and better removal of B2 microglobulin and phosphorous Objective: The aim of this study is to compare effect of high flux (HF), low flux (LF) dialysis membranes and hemodiafiltration (HDF) on the metabolic status in hemodialysis patients and quality of life of those patients. Patients and Methods: This study included 60 patients more than18 years old, clinically stable with end stage renal disease on regular HD for at least three years (3 yrs), selected from HD unit in (Kobry El Kobba Military Nephrology Hospital) in the period from March 2018 to September 2018. The patients were divided into three groups equally. Group I: 20 patients on low flux dialyzer, Group II: 20 patients on high flux dialyzer, Group III: 20 patients on hemodiafiltration. Results: There was a highly significant decrease in iPTH, B2 microglobulin and Phosphorous in patients received HDF (363.80±149.04, 8.79±7.22 and 4.31±0.74 respectively in comparison with patients received HF hemodialysis (540.10±242.55, 20.47±3.97and 4.58±1.07 respectively) and patients received LF hemodialysis (725.95±270.01, 36.60±7.22 and 5.73±1.34 respectively). Also, there were a highly significant increase in urea reduction ratio in HDF group compared to HF and LF groups (80.43±7.46, 76.03±9.55 and 65.81±7.42 respectively. Conclusion: Hemodiafiltration is the most effective dialysis technique than high flux and low flux dialysis membrane in removal of medium sized molecule and improvement of quality of life. [ABSTRACT FROM AUTHOR]

L'hémodiafiltration en ligne est une technique de dialyse présentant de nombreux avantages, toutefois son utilisation reste limitée par souci de non-maîtrise des risques microbiologiques. Au cours de ce travail, nous réalisons une analyse des risques liés au procédé de production du liquide de substitution au cours de l'hémodiafiltration en ligne et nous validons ce procédé, d'un point de vue microbiologique. L'analyse des risques a été réalisée suivant la démarche d'analyse des modes de défaillances, de leurs effets et de leurs criticités. Elle a permis d'identifier les « pires cas » du procédé de production étudié. Pour la validation de ce procédé, nous avons utilisé le test au lysat d'amoebocytes de limule pour la recherche d'endotoxines bactériennes et le test de filtration sur membrane pour le contrôle de la stérilité. Nous avons recensé 17 modes de défaillances dont 13 étaient acceptables. Les modes de défaillances ayant dépassé le seuil d'acceptabilité ont été définis comme « pires cas ». Le contrôle de la stérilité et la recherche des endotoxines, réalisés dans les « pires cas », ont permis de vérifier la conformité de la qualité microbiologique du liquide produit aux normes requises et, par la suite, de valider le procédé utilisé. Cette démarche a permis de recenser le plus grand nombre possible des modes de défaillances. La validation dans « les pires cas » représente un défi extrême au procédé et sa réussite constitue une base suffisante pour conclure que la technique est sûre et, par conséquent, pour valider le procédé. Ce travail nous a permis de valider notre procédé de production dans des cas extrêmes favorisant une utilisation plus sûre de la technique. Online hemodiafiltration is a technique of dialysis with many advantages, but its use is limited because of the lack of control of microbiological risks. This work conducts a risk analysis of the process for producing substitution liquid for online hemodiafiltration and validates this process from a microbiological point of view. The risk analysis was carried out following the approach of analysing failure modes, their effects and their criticalities. It identified the "worst case" of the production process being studied. For the validation of this process, we used the limulus amoebocytes lysate assay for bacterial endotoxins and the membrane filtration test for sterility control. We identified 17 failure modes, 13 of which were acceptable. Failure modes that exceeded the acceptability threshold were defined as "worst cases". Sterility monitoring and endotoxin testing, conducted in the "worst case", verified the microbiological quality of the liquid produced to the required standards and subsequently validated the process used. This approach has resulted in the identification of as many failure modes as possible. Validating in "worst case" is an extreme challenge to the process and its success provides a sufficient basis to conclude that the technique is safe and, therefore, to validate the process. This work has enabled us to validate our production process in extreme cases to promote safer use of the technique. [ABSTRACT FROM AUTHOR]

Uremic toxins play a pathological role in atherosclerosis and represent an important risk factor in dialysis patients. Online hemodiafiltration (HDF) has been introduced to improve the clearance of middle- and large-molecular-weight solutes (>500 Da) and has been associated with reduced cardiovascular mortality compared to standard hemodialysis. This non-randomized, open-label observational study will explore the efficacy of two dialyzers currently used for online HDF, a polysulfone-based high-flux membrane, and a cellulose triacetate membrane, in hemodialysis patients with signs of middle-molecule intoxication or intradialytic hypotension. In particular, the two filters will be evaluated for their ability in uremic toxin removal and modulation of inflammatory status. Sixteen subjects in standard chronic bicarbonate hemodialysis requiring a switch to online HDF in view of their clinical status will be enrolled and divided into two treatment arms, according to the previous history of hypersensitivity to polysulfone/polyethersulfone dialysis filters and hypersensitivity to drugs or other allergens. Group A will consist of 16 patients without a previous history of hypersensitivity and will be treated with a polysulfone filter (Helixone FX100), and group B, also consisting of 16 patients, with a previous history of hypersensitivity and will be treated with asymmetric triacetate (ATA; SOLACEA 21-H) dialyzer. Each patient will be followed for a period of 24 months, with monthly assessments of circulating middle-weight toxins and protein-bound toxins, markers of inflammation and oxidative stress, lymphocyte subsets, activated lymphocytes, and monocytes, cell apoptosis, the accumulation of advanced glycation end-products (AGEs), variations in arterial stiffens measured by pulse wave velocity (PWV), and mortality rate. The in vitro effect on endothelial cells of uremic serum collected from patients treated with the two different dialyzers will also be investigated to examine the changes in angiogenesis, cell migration, differentiation, apoptosis and proliferative potential, and gene and protein expression profile. The expected results will be a better awareness of the different effects of polysulfone gold-standard membrane for online HDF and the new ATA membrane on the removal of uremic toxins removal and inflammation due to blood–membrane interaction.

Background: acute kidney injury (AKI) has arisen as a global public health problem and associated with high morbidity and mortality where the AKI mortality is more than 50%. It is a serious complication frequently occurred in ICU In hospitalized patients, 15% of them developed AKI and around 40% of AKI patients were referred to ICU. Objective: The aim of this study was to compare between effect of Sustained Low Efficiency Hemodialysis and Online Hemodiafiltration in Critically Ill patients with Acute Kidney Injury. Patients and Methods: This prospective study included a total of forty (age and sex matched) patients with Acute Kidney Injury (AKI) who were critically ill, attending at Nephrology Unit, Bab El-Shaareya, Al-Azhar University Hospitals. The patients were divided into 2 groups; Group (A): 20 patients on Sustained Low Efficiency Hemodialysis (SLED) and Group (B): 20 patients on Online Hemodiafiltration (OLHDF). Results: there was no significant difference between the two groups as regard Intradialytic hypotension (2 patients (10%) in group 1 and 5 patients in group 2 (25%) p-value = 0.2). There was no significant difference between the two groups as regard weaning from ventilator (4 patients (40%) in group 1 and 3 patients in group 2 (42.8%) p-value = 0.5). Conclusion: Online haemodiafiltration (OL-HDF) showed to be better than IHD-LI in many aspects but there was no statistically significant difference in mortality, allowing us to recommend as first choice OL-HDF of treatment proposed for critically ill patients with acute kidney injury. [ABSTRACT FROM AUTHOR]

Restoring and controlling fluid volume homeostasis is still a challenge in contemporary end‐stage kidney disease patients treated by intermittent hemodialysis (HD) or hemodiafiltration (HDF). This primary target is achieved by ultrafiltration (dry weight probing) and control of intradialytic sodium transfer (dialysate‐plasma Na gradient). The latter task is mostly ignored in clinical practice by applying a dialysate sodium prescription uniform for all patients of the dialysis center but unaligned to individual plasma sodium levels. Depending on the patient's natremia, a positive gradient gives rise to intradialytic diffusive sodium load and postdialytic thirst. On the contrary, a negative gradient may cause unwanted diffusive sodium removal and intradialytic symptoms. To overcome these challenges, a new conductivity‐based electrolyte balancing algorithm embedded in a hemodialysis machine with the aim to achieve "zero diffusive sodium balance" in HD and online HDF treatments was tested in the form of a prospective clinical trial. The study comprised two phases: a first phase with a conventional fixed‐sodium dialysate (standard care phase), followed by a phase with the electrolyte balancing control (EBC) module activated (controlled care phase). The results show a reduction in the variability of the intradialytic plasma sodium concentration shift, but it is overlain by a small but statistically significant increase in the mean plasma sodium levels. However, no clinical manifestations were observed. This sodium load can be explained by the design of the algorithm based on dialysate conductivity instead of sodium concentration. Furthermore, the increase in plasma sodium can be corrected by taking into account the potassium shift during the treatment. This study showed that the EBC module incorporated in the HD machine is able to automatically individualize the dialysate sodium to the patient's plasma sodium without measuring or calculating predialytic plasma levels from previous laboratory tests. This tool has the potential to facilitate fluid management, to control diffusive sodium flux, and to improve intradialytic tolerance in daily clinical practice. [ABSTRACT FROM AUTHOR]

Background: Recent evidence suggests a better reduction rate of some uremic toxins with expanded hemodialysis (HDx). Methods: Prospective study including 8 hemodialysis patients. We divided the study in 2 phases; within the first one, we assigned 4 patients (group 1) to undergo online hemodiafiltration with a PF 210H dialyzer, and the other 4 patients (group 2) to undergo HDx with the high retention onset Theranova 500 dialyzer during 24 sessions. Later, during the second phase and after a washout period, the same patients were switched to receive HDx (group 1) and HDF (group 2). Results: No differences were found in the Urea and β2-microglobulin reduction ratio. However, in the case of myoglobin, the reduction ratio with HDF was 35 vs. 60% with HDx (p < 0.001). Similarly, in the case of prolactin, the reduction ratio with HDF was 45 and 61% with HDx (p < 0.001). Conclusions: We conclude that HDx is not inferior to online hemodiafiltration in the clearance of small and middle molecules and could be superior in the clearance of larger middle molecules. [ABSTRACT FROM AUTHOR]