High-flux Dialysis Research Articles

Acute effects of online hemodiafiltration versus high-flux hemodialysis on serum levels of asymmetric dimethylarginine and tumor necrosis factor-alpha

Background Chronic inflammation as a major determinant of ‘dialysis syndrome’ is considered as the main factor of morbidity and mortality in dialysis patients. Tumor necrosis factor-alpha (TNF-α) may play important roles in the development of T helper (Th) imbalance, cardiovascular disease, and wasting in the uremic milieu. Asymmetric dimethylarginine (ADMA) is an endogenous inhibitor of nitric oxide that may be an independent risk factor for endothelial dysfunction and cardiovascular disease. In hemodialysis (HD) patients, plasma ADMA is a strong and independent predictor of overall mortality and cardiovascular outcome. The aim of this study to evaluate the acute effects of hemodiafiltration (HDF) compared with conventional HD on blood levels of ADMA and TNF-α. Patients and methods A cross-sectional study was conducted on 20 patients with end-stage renal disease receiving dialysis in the dialysis unit of Ain Shams Specialized Hospital receiving twice weekly HD session with high-flux (HF) dialyzer and once weekly HDF session. Blood samples were collected from all participants before and after HD session and from the same participants before and after HDF session. ADMA and TNF-α levels were assessed by enzyme-linked immunosorbent assay techniques. Results The decrease in TNF-α was higher after HDF session versus HF HD session (79.47 ± 14.16 vs. 50.43 ± 31.05), with P value of 0.001. Moreover, the decrease in ADMA was higher after HDF session versus HF HD session (75.01 ± 12.55 vs. 41.79 ± 24.73), with P value of 0.001. Conclusion The use of online HDF technique showed a significant reduction of ADMA and TNF-α in adults with end-stage renal disease.

EE96 Budget-Impact Analysis of Adopting Expanded Hemodialysis (HDX) Via Theranova® in Korea

HD (Hemodialysis) is the dominant modality among ESRD patients in Korea, so the role of dialyzer is quite important for treatment outcomes. Theranova® (dialyzer of expanded hemodialysis, HDx) is a medium cut-off dialyzer that allows for better clearance of large middle molecules than traditional high-flux dialyzers. Compared to high flux HD, HDx via Theranova® has been associated with reduced treatments for anemia and lower risk of all-cause and cardiovascular hospitalization. This budget impact analysis evaluates healthcare costs aligned with clinical factor between Theranova® and conventional hemodialysis (HD) with a high-flux dialyzer in Korea.

Evaluation of VIE-X Filter Performances vs. Medium Cut-Off Dialyzer and High-Flux Dialyzers on Protein Loss and Inflammatory Status of Chronic Hemodialysis Patients

Evaluation of VIE-X Filter Performances vs. Medium Cut-Off Dialyzer and High-Flux Dialyzers on Protein Loss and Inflammatory Status of Chronic Hemodialysis Patients

The Effect of Hemodiafiltration vs. High-Flux Dialysis on Middle- and Large-Sized Molecules' Reduction and Its Relation to Albumin Loss Using Big Surface-Area Dialyzer 2.6 m2

The Effect of Hemodiafiltration vs. High-Flux Dialysis on Middle- and Large-Sized Molecules' Reduction and Its Relation to Albumin Loss Using Big Surface-Area Dialyzer 2.6 m2

Comparative Effectiveness in Removing Uremic Toxins Between Hemodialysis With Reuse and Single-Use Super High-Flux Dialyzer

Comparative Effectiveness in Removing Uremic Toxins Between Hemodialysis With Reuse and Single-Use Super High-Flux Dialyzer

Comparison of High-Flux, Super High-Flux, Medium Cut-Off Hemodialysis and Online Hemodiafiltration on the Removal of Uremic Toxins

Introduction: Online hemodiafiltration (OL-HDF) and hemodialysis (HD) using high-performance membranes such as adsorptive, medium cut-off (MCO), and super high-flux (SHF) dialyzers have been implemented to enhance the removal of middle molecules (MM). The aim of this study was to compare the efficacy of different dialysis strategies and dialyzers on small solutes and MM reduction ratio (RR) and mass removal. Methods: We performed a prospective study in 8 HD patients. Each patient underwent 9 dialysis sessions: seven sessions on HD using either Theranova 500™, Elisio 21H™, Renak PS-2.0W™, Filtryzer BK-2.1F™, Vie 21X™, TS-2.1UL™ or FDY 210-GW™ dialyzers and two sessions on OL-HDF using Elisio 21H™ or Renak PS-2.0W™ dialyzers. Results: Urea mass removal and RR were similar between all dialysis strategies. The lowest beta2-microglobulin RR was achieved with Filtryzer BK-2.1F™ HD (p < 0.05). Compared to Elisio 21H™ HD, Renak PS-2.0W™ OL-HDF produced higher beta2-microglobulin mass removal (181 ± 46 vs. 317 ± 161 mg, p < 0.05). Theranova 500™ HD, Vie 21X™ HD, FDY 210-GW™ HD, Elisio 21H™ OL-HDF, and Renak PS-2.0W™ OL-HDF induced higher RR for kappa and lambda FLC, as compared to Elisio 21H™ HD and Filtryzer BK-2.1F™ HD (p < 0.05). Renak PS-2.0W™ OL-HDF achieved higher kappa FLC mass removal compared to Elisio 21H™ HD (563 ± 515 vs. 141 ± 47 mg, p < 0.01) and to Renak PS-2.0W™ HD (563 ± 515 vs. 153 ± 25 mg, p < 0.05). Albumin loss varied from 0.02 ± 0.05 to 7.6 ± 3.8 g/session with Elisio 21H™ HD and Renak PS-2.0W™ OL-HDF, respectively. Compared to all other strategies, Renak PS-2.0W™ OL-HDF induced a significantly higher albumin loss (p < 0.05). Conclusion: This study confirms that albumin loss and removal of MM are similar using conventional Elisio 21H™ OL-HDF, MCO-HD, and SHF type V dialyzers. Although Renak PS-2.0W™ OL-HDF provides high performance for MM depuration, this protein-permeable dialyzer should not be used in OL-HDF because of excessive albumin loss.

Effects of high albumin leakage on survival between online hemodiafiltration and super high-flux hemodialysis: the HISTORY study

BackgroundAll-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.MethodsIn 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.ResultsAll-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.ConclusionsThe 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.

High-Flux dialyzer 2.6 m2 is promising for free light chains removal in high-flux hemodialysis and in hemodiafiltration

Immunoglobulin light chains are classified as middle molecule uremic toxins and its removal through effective dialyzer is needed with less albumin loss. This study assessed the free light chains (FLC) removal using dialyzer surface area (SA) 2.6m2 in high-flux dialysis (HF-HD) versus hemodiafiltration (HDF) and its relation to cumulative dialysate albumin loss. This pilot cross-over study included 25 patients who underwent hemodialysis (HD) using dialyzer surface area 2.6m2 on HF-HD followed by online post-dilution HDF with washout period of 2 weeks using high-flux dialyzers (max 2.0 m2 SA). All patients were subjected to single session measurement of dialysate albumin every hour and pre/post dialysis levels of FLC Kappa (Κ) and Lambda (λ) by ELISA. Dialyzer (SA) 2.6m2 showed a significant reduction in post-dialysis kappa and lambda level in comparison to pre-dialysis level on HF-HD and hemodiafiltration (P<0.001). HDF showed higher kappa and lambda FLC reduction ratio (45.16 ± 6.53 %, 28.68 ± 4.36 %, respectively compared to HF-HD (29.52 ± 6.38 %, 19.48 ± 1.96, respectively, P<0.001 for both). Patients on HDF dialysis had significant total albumin loss in dialysate [median (IQR) 2.97; 1.98 - 3.37 gm] compared to HF-HD [median (IQR) 0.67; 0.49 - 1.13 gm] (P <0.001). In conclusion, high-flux dialyzer 2.6 m2 (SA) may be effective in free light chains removal especially with online post-dilution hemodiafiltration with acceptable albumin loss.

Basic physics of hemodiafiltration.

Standard high-flux hemodialysis (HD) clears urea very efficiently but is less efficient at clearing uremic toxins with larger molecule size, which diffuse more slowly. Hemodiafiltration (HDF) provides much higher convection rates, thereby reliably increasing the clearance of these larger toxins. However, the high ultrafiltration volumes employed by HDF significantly increase the concentration of proteins and lipids in the dialyzer blood compartment. This has the effect of increasing plasma viscosity, which opposes solute diffusion, and increasing plasma oncotic pressure, which opposes convection. The negatively charged plasma proteins also influence the equilibration of ions between dialysate and blood compartments. These effects result in varying conditions for solute transport along the length of the dialyzer and along the radial distance from the membrane within the dialyzer fibers. High-flux dialyzers can be designed to augment solute diffusion and internal filtration, so that their performance approaches that of HDF. This avoids some of the mechanical complexity of HDF, but such enhanced dialyzers may be more difficult to manufacture, control and monitor. Here, we present and discuss the most important physical phenomena associated with HDF therapy, providing an overview of its main concepts and principles. In particular, we discuss the physics of solute diffusion and convection and the factors affecting them, and we compare predilution or postdilution HDF with enhanced HD.

High Flux Versus Low Flux Dialysis: Impact on Intradialytic Hypertension and Adequacy of Dialysis

High Flux Versus Low Flux Dialysis: Impact on Intradialytic Hypertension and Adequacy of Dialysis

The high-volume haemodiafiltration vs high-flux haemodialysis registry trial (H4RT): a multi-centre, unblinded, randomised, parallel-group, superiority study to compare the effectiveness and cost-effectiveness of high-volume haemodiafiltration and high-flux haemodialysis in people with kidney failure on maintenance dialysis using linkage to routine healthcare databases for outcomes

BackgroundMore than a third of the 65,000 people living with kidney failure in the UK attend a dialysis unit 2–5 times a week to have their blood cleaned for 3–5 h. In haemodialysis (HD), toxins are removed by diffusion, which can be enhanced using a high-flux dialyser. This can be augmented with convection, as occurs in haemodiafiltration (HDF), and improved outcomes have been reported in people who are able to achieve high volumes of convection. This study compares the clinical- and cost-effectiveness of high-volume HDF compared with high-flux HD in the treatment of kidney failure.MethodsThis is a UK-based, multi-centre, non-blinded randomised controlled trial. Adult patients already receiving HD or HDF will be randomised 1:1 to high-volume HDF (aiming for 21+ L of substitution fluid adjusted for body surface area) or high-flux HD. Exclusion criteria include lack of capacity to consent, life expectancy less than 3 months, on HD/HDF for less than 4 weeks, planned living kidney donor transplant or home dialysis scheduled within 3 months, prior intolerance of HDF and not suitable for high-volume HDF for other clinical reasons. The primary outcome is a composite of non-cancer mortality or hospital admission with a cardiovascular event or infection during follow-up (minimum 32 months, maximum 91 months) determined from routine data. Secondary outcomes include all-cause mortality, cardiovascular- and infection-related morbidity and mortality, health-related quality of life, cost-effectiveness and environmental impact. Baseline data will be collected by research personnel on-site. Follow-up data will be collected by linkage to routine healthcare databases — Hospital Episode Statistics, Civil Registration, Public Health England and the UK Renal Registry (UKRR) in England, and equivalent databases in Scotland and Wales, as necessary — and centrally administered patient-completed questionnaires. In addition, research personnel on-site will monitor for adverse events and collect data on adherence to the protocol (monthly during recruitment and quarterly during follow-up).DiscussionThis study will provide evidence of the effectiveness and cost-effectiveness of HD as compared to HDF for adults with kidney failure in-centre HD or HDF. It will inform management for this patient group in the UK and internationally.Trial registrationISRCTN10997319. Registered on 10 October 2017

Effects of Low-Flux and High-Flux Dialysis Membranes on Erythropoietin Responsiveness in Hemodialysis Patients.

Background Chronic kidney disease (CKD) is often accompanied by anemia. High-flux membranes contribute to a reasonable removal of uremic toxins which cause anemia in CKD. Inadequate data have described the efficiency of high-flux dialysis in promoting erythropoietin responsiveness in CKD patients in the Middle East. This study was conducted to compare the efficiency of maintaining high-flux hemodialysis versus low-flux dialysis for ≥1 year in promoting erythropoietin responsiveness and to show the factors associated with erythropoietin hyporesponsiveness in Arab chronic hemodialysis patients. Methods It was a retrospective cohort study that involved 110 subjects who were categorized into group 1 (50 patients receiving low-flux dialysis) and group 2 (60 patients receiving high-flux dialysis). History taking, examination, and laboratory investigations were conducted for all patients every 3 months from January 2021 to January 2022. Results Group 2 had significantly higher weight and body mass index than group 1 but lower cholesterol and intact parathyroid hormone levels than group 1. Erythropoietin resistance index levels did not differ between the two groups upon repeated measures over a 1-year follow-up. Significant risk factors for erythropoietin hyporesponsiveness on multivariate analysis were lower weight (Odds ratio (OR): 0.966; 95% Confidence interval (CI): 0.94–0.992; p=0.011), longer hemodialysis vintage (OR: 1.172; 95% CI: 1.036–1.325; p=0.012), lower hemoglobin levels (OR: 0.531; 95% CI: 0.362–0.779; p=0.001), and higher neutrophil-to-lymphocyte ratio (OR: 2.436; 95% CI: 1.321–4.493; p=0.004). Conclusion High-flux dialysis was not superior to low-flux dialysis in improving erythropoietin responsiveness.

MO889: High Flux Dialyzer 2.6 M2 is Promising for Free Light Chains Removal in High Flux Hemodialysis and Hemodiafiltration

Abstract BACKGROUND AND AIMS Immunoglobulin light chains are classified as middle molecule uremic toxins and its removal through effective dialyzer is needed with less albumin loss. This study assessed the free light chains removal using dialyzer surface area (SA) 2.6m2 in high flux dialysis (HD) versus hemodiafiltration (HDF) and its relation to cumulative albumin loss. METHOD A cross-over study included 25 patients who underwent hemodialysis using dialyzer surface area 2.6 m2 in high flux HD followed by online post-dilution hemodiafiltration with washout period 2 weeks using high flux dialyzers (max 2.0 m2 SA). All patients were subjected to single session measurement of dialysate albumin every hour and pre-post dialysis Free light chains (FLC) kappa and Lambda by ELISA. RESULTS Dialyzer (SA) 2.6m2 showed significant reduction in post-dialysis kappa and lambda in comparison to pre-dialysis level in high flux hemodialysis and hemodiafiltration (P &amp;lt; 0.001). HDF showed higher kappa and lambda FLC reduction ratio (45.16 ± 6.53 ng/mL), (28.68 ± 4.36 ng/mL), respectively compared with high flux HD (29.52 ± 6.38 ng/mL), (19.48 ± 1.96 ng/mL), respectively (P &amp;lt; 0.001). HDF/HD fold change of kappa and lamda were (1.56 ± 0.23) and (1.48 ± 0.26), respectively. Patients on HDF dialysis had significant total albumin loss in dialysate [median (IQR) 2.47 (1.16) gm/dL] compared with high flux dialysis [median (IQR) 0.65 (0.64) gm/dL] with (P &amp;lt; 0.001). Maximum albumin loss in patients on HDF was in the first hour [median (IQR) 1.22 (0.59)] gm/dL with lower albumin loss in the next hours reaching median {0.17 (0.15) gm/dL} in the fourth hour. Trans-membrane pressure was positively correlated with total albumin loss in high flux hemodialysis and hemodiafiltration (r 0.443, p 0.027, r 0.745, P = 0.001), respectively. CONCLUSION High flux dialyzer 2.6 m2 (SA) is effective for free light chains removal especially with online post-dilution hemodiafiltration with acceptable albumin loss.

MO646: Effect of a High-Flux Dialyzer Applied to HFR Supra on the Removal of Large Uraemic Toxins in Haemodialysis Patients: Results from a Randomized Controlled Study

Abstract BACKGROUND AND AIMS HFR-Supra (haemodiafiltration with the regeneration of the ultrafiltrate) is a highly biocompatible dialysis technique characterized by an adsorptive resin cartridge with high protein-bound toxin adsorption capacity without removal of albumin, mimicking both glomerular and tubular functions. However, the low-flux dialyzer contained in the second diffusive stage of the HFR Supra system may hamper the removal of large uraemic toxins. This study assessed the large uraemic toxin removal ability of a new HFR system (HFR-H) which combines adsorption such as in HFR-Supra, with a high-efficiency high-flux haemodialysis membrane. METHOD In an open, randomized, cross-over, single-center, controlled study, 16 adult chronic haemodialysis patients were treated by haemodiafiltration with the regeneration of the ultrafiltrate with the HFR-Supra or the HFR-H system. All other dialysis parameters were kept constant in both study arms. All the treatments were delivered with Flexya dialysis monitor (Medtronic) in the middle-week session, lasting 4-h. The reduction rate (RR) of urea, creatinine, phosphate, β2-microglobulin, kappa (κFLC) and lambda (λFLC) free light chains and albumin, was intra-individually compared for the two dialysis types with linear mixed models. RESULTS The RRs for β2-microglobulin, κFLC and λFLC were significantly higher with the HFR-H system than those obtained with HFR-Supra (Figure). There were no significant differences in the RR for urea, creatinine, phosphate, interleukin-6 and albumin. CONCLUSION This study demonstrates that treating patients with an HFR-H instead of an HFR-Supra system significantly increases the elimination of middle and large molecules.

MO642: Comparison of Medium Cut-Off Dialyzer and Post-Dilution Hemodiafiltration on the Removal of Small and Middle Molecule Uremic Toxins

Abstract BACKGROUND AND AIMS The medium cut-off (MCO) dialyzer increases the removal of several middle molecules more effectively than high-flux hemodialysis (HD). However, there are no comparable data on the efficacy and safety of MCO dialyzers versus post-dilution hemodiafiltration (HDF) in Korean patients. METHOD A total of 9 patients with chronic HD were included in this crossover study. Patients received HD with an MCO dialyzer for 4 weeks, followed by a 2-week washout period, using a high-flux dialyzer to minimize carry-over effects and then crossed over to post-dilution HDF for 4 weeks. Reduction ratios and differences in the values before and after were calculated from the MCO dialysis, post-dilution HDF and high-flux HD. In the in vitro study, EA.hy926 cells were treated with dialyzed serum. RESULTS Compared with post-dilution HDF, the MCO dialyzer achieved significantly higher reduction ratios for larger middle molecules [myoglobin, kappa free light chain (κFLC) and lambda FLC (λFLC)]. Similarly, the differences between before and after the last dialysis session of myoglobin, κFLC, and λFLC were significantly greater in MCO dialysis than in post-dilution HDF. The expression of Bax and nuclear factor-κb was decreased in the serum after dialysis with the MCO dialyzer than with HDF. CONCLUSION Compared with high-volume post-dilution HDF, MCO dialysis showed no differences in the removal of molecules below 12 000 Da, whereas it was superior in the removal of larger uremic middle molecule toxins in patients with kidney failure. Moreover, these results might be expected to have an anti-apoptotic effect on the human endothelium.

MO661: Elimination of Middle and Large Uraemic Toxins in Short Daily Home Haemodialysis with Low Dialysate Volume: A Randomized Crossover Clinical Trial

Abstract BACKGROUND AND AIMS Portable haemodialysis (HD) systems with a low dialysate flow rate in a short frequent schedule have become an attractive option for patients on home HD (HHD). Although these systems have been demonstrated to be effective for removing low weight molecular uraemic toxins, there are few data on their removal ability of higher molecular weight toxins. This study assessed the uraemic toxin removal ability of the portable Physidia S3 Monitor in a short, frequent, 5 days/week, low-dialysate flux HHD versus 3 days/week, in centre online haemodiafiltration (OL-HDF). METHOD In an open, randomized, cross-over, single-centre, controlled, prospective study, 40 adult chronic HD patients were treated by a 2.5-h low flux dialysate HD session or a 4-h post-dilution OL-HDF. All other dialysis parameters including dialyzer (polysulfone high-flux dialyzer NS 1.8, Toray®) were kept constant in both the study arms. The weekly reduction rate (RR) and the weekly eliminated mass into dialysate (EM) of urea, creatinine, phosphate, β2-microglobulin, kappa (κFLC) and lambda (λFLC) free light chains and albumin, were intra-individually compared for the two dialysis types with linear mixed models. RESULTS There were no significant differences in the RR for urea, phosphate, κFLC and albumin, whereas the weekly RRs for creatinine and β2-microglobulin were significantly higher with the Physidia S3 system than those obtained with OL-HDF (Table). Only the λFLC RR was significantly higher with OL-HDF. Similar results were observed when weekly EMs were compared (data not shown). CONCLUSION This study demonstrates that treating patients with low flow dialysate HHD in a short frequent schedule with Physidia S3 system, instead of 3 days/week, in-centre OL-HDF, significantly increases the weekly elimination of β2-microglobulin, enabling an adequate clearance of small and large uraemic toxins.

Accumulation of Advanced Glycation End Products Independently Increases the Risk of Hospitalization Among Hemodialysis Patients

Objective: To determine the association between AGE accumulation detected by skin-autofluorescence (SAF) and hospitalization among ESKD patients.Materials and Methods: 196 ESKD patients from two hemodialysis (HD) units in Bangkok were enrolled in this retrospective study from November 2015 to March 2016. Before HD treatment, AGEs were measured with the SAF device on the area with intact skin on the volar surface of the non-fistula arm. The study concluded in December 2020, and the number of and causes of hospitalization were reviewed. A logistic regression model was used to determine the association between SAF level and patient hospitalization.Results: Of the 196 patients enrolled in the study, SAF was measured in 165 patients with a mean (SD) age of 69.2 (13.0) years. Most of the participants were non-smokers who had hypertension and diabetes and were on high-flux dialyzers. The average weekly spKt/V was 2.1, and the mean (SD) SAF was 3.05 (0.81) AU. The group with high SAF consisted of older patients and had a higher proportion of diabetics and smokers, but this was not statistically significant when compared to the low SAF group. In the multivariable analysis model, SAF greater or equal to 3.05 AU (OR = 2.28; 95% CI, 1.05–4.94; P &lt; 0.05) and increased age (OR = 1.05; 95% CI, 1.01–1.09; P &lt; 0.05) were associated with an increased risk of hospitalization.Conclusion: Higher values of age and SAF were independently associated with increased risk of hospitalization among ESKD patients.

Economic evaluation of expanded hemodialysis with the Theranova 400 dialyzer: A post hoc evaluation of a randomized clinical trial in the United States.

IntroductionThe Theranova 400 is a medium cut‐off dialyzer that allows for superior clearance of larger middle molecules than traditional high‐flux dialyzers. This study evaluates the association of expanded hemodialysis (HDx) using the Theranova dialyzer versus conventional hemodialysis (HD) with a high‐flux dialyzer on hospitalization rates and healthcare costs as compared to conventional HD in a post hoc analysis of a randomized controlled trial.MethodsIn a non‐concealed, 24‐week clinical trial, maintenance HD patients were randomized to receive treatment with either Theranova 400 or a similar size high‐flux dialyzer. Hospitalization rate and average length of stay were calculated from trial data. Use of erythropoiesis‐stimulating agents and iron were assumed to be equal and therefore excluded from the model. Average cost per inpatient day was obtained from a publicly available published source. Probabilistic sensitivity analyses were conducted to account for variability in model inputs.FindingsThere were 86 patients (389 patient‐months) in the Theranova group and 85 patients (366 patient‐months) in the high‐flux HD group. All‐cause hospitalization rate was 45% lower with Theranova compared to high‐flux HD (IRR = 0.55; p = 0.05). Average annual estimated cost of hospitalization was $6098 lower with Theranova compared to high‐flux HD. Compared to high‐flux HD, average annual estimated cost associated with Theranova use was $4772 lower per patient. Hospitalization rate and hospital length of stay were the main drivers of cost.ConclusionsUse of the Theranova dialyzer is associated with lower estimated costs of care among maintenance HD patients, driven by fewer hospitalization events.

Global real-world data on hemodiafiltration: An opportunity to complement clinical trial evidence.

Hemodiafiltration (HDF) is a renal replacement therapy that utilizes both diffusive clearance and convective transport to achieve greater clearance of middle-molecular-weight solutes. Among other factors, important prerequisites for the implementation of HDF include access to high-flux dialyzers, achievement of high blood flow rates, and availability of high volumes of sterile substitution/replacement fluids. Online hemodiafiltration (OL-HDF) is an established kidney replacement therapy, frequently used in many countries. Although in the United States, some prerequisites (e.g., access to high-flux dialyzers and achievement of high blood flow rates) for OL-HDF treatment are readily available; however, a machine capable of generating the online solution for OL-HDF is currently not available. As the clinical experience with HDF accumulates globally, it is worth examining the evidence for this kidney replacement therapy as used in routine clinical care. Such real-world evidence is increasingly recognized as valuable by clinicians and may inform regulatory decisions. In this review, we will focus on emerging global real-world data derived from routine clinical practices and examine how these data may complement those derived from clinical trials.

Clinical Safety of Expanded Hemodialysis Compared with Hemodialysis Using High-Flux Dialyzer during a Three-Year Cohort.

Expanded hemodialysis (HD) equipped with a medium cut-off (MCO) membrane provides superior removal of larger middle molecules. However, there is still little research on the long-term benefits of expanded HD. Over a three-year period, this observational study evaluated the efficacy and safety profile of expanded HD for inflammatory cytokines, including IL-6. We conducted a prospective cohort study to investigate the inflammatory cytokine changes and a retrospective observational cohort study to investigate long-term clinical efficacy and safety over a three-year period. We categorized the patients according to dialyzer used: MCO and high-flux (HF) dialyzer. The inflammatory cytokines, including IFN-γ, IL-1β, IL-6, and TNF-α, were measured annually. The concentrations and changes of the four cytokines over time did not differ between the HF group (n = 15) and MCO group (n = 27). In both prospective and retrospective (HF group, n = 38; MCO group, n = 76) cohorts, there were no significant differences in either death, cardiovascular events, infections, or hospitalizations. Furthermore, the temporal changes in laboratory values, including serum albumin and erythropoietin prescriptions, did not differ significantly between the two groups in either the prospective or retrospective cohorts. In conclusion, clinical efficacy and safety outcomes, as well as inflammatory cytokines, did not differ with expanded HD compared with HF dialysis during a three-year treatment course, although the level of inflammatory cytokine was stable.