scholarly journals Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer

2020 ◽  
Vol 15 (9) ◽  
pp. 1310-1319 ◽  
Author(s):  
Daniel E. Weiner ◽  
Luke Falzon ◽  
Line Skoufos ◽  
Angelito Bernardo ◽  
Werner Beck ◽  
...  
Keyword(s):  
Serum Albumin ◽  
Serum Albumin Level ◽  
Albumin Level ◽  
Reduction Ratio ◽  
Light Chains ◽  
Maintenance Hemodialysis ◽  
High Flux ◽  
Efficacy And Safety ◽  
End Point ◽  
Middle Molecules

Background and objectivesExpanded hemodialysis therapy enabled by medium cut-off membranes may promote greater clearance of larger middle molecules that comprise putative uremic solutes than conventional high-flux dialysis. This randomized trial evaluated the efficacy and safety of hemodialysis treatment with a medium cut-off dialyzer.Design, setting, participants, & measurementsClinically stable patients on maintenance hemodialysis were randomized to receive dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H) over 24 weeks of treatment. The primary safety end point was the predialysis serum albumin level after 24 weeks of treatment. The primary efficacy end point was the reduction ratio of free λ light chains at 24 weeks of treatment.ResultsAmong 172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years. Of the 86 patients randomized to each dialyzer, 65 completed the trial in each group. The reduction ratio for the removal of free λ light chains was significantly higher in the Theranova 400 group compared with the Elisio-17H group after 4 weeks (39% versus 20%) and 24 weeks (33% versus 17%; both P<0.001). Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free κ light chains, TNFα, and β2-microglobulin (P<0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.ConclusionsHemodialysis therapy with the Theranova 400 dialyzer provides superior removal of larger middle molecules, as exemplified by free λ light chains, compared with a similar size high-flux dialyzer, while maintaining serum albumin level.Clinical Trial registry name and registration numberA Multi-Center, Prospective, Randomized, Controlled, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer in End Stage Renal Disease (ESRD) Patients, NCT03257410.

scholarly journals In maintenance hemodialysis patients, there were “U-shaped” relationships between serum albumin level and mortality or hospitalization, negative linear relationship between serum albumin level and hospitalization for infection.

2019 ◽  
Author(s):  
Xiaoyan Jia ◽  
Ping Chen ◽  
Xue Wang ◽  
Xianglei Kong ◽  
Juan Chen ◽  
...  
Keyword(s):  
Serum Albumin ◽  
Cerebrovascular Disease ◽  
Linear Relationship ◽  
Serum Albumin Level ◽  
Cox Regression ◽  
Albumin Level ◽  
Maintenance Hemodialysis ◽  
Linear Association ◽  
Non Linear ◽  
Negative Linear Relationship

Abstract Background: Few studies are available on the non-linear association between serum albumin (S-Alb) level and prognosis in maintenance hemodialysis (MHD) patients. Methods: All stable MHD patients treated in our center from 2007 to 2011 were enrolled into this study. Demographics, laboratory data, hospitalization and mortality were collected; Cox regressive models were fitted to investigate predicting outcomes, restricted cubic splines (RCS) were allowing for non-linear association between S-Alb and prognosis. Results: S-Alb was independent protective factor for mortality, all-cause hospitalization, hospitalization for cardiovascular or cerebrovascular disease and hospitalization for infection. The relationships between S-Alb and mortality, all-cause hospitalization, hospitalization for cardiovascular or cerebrovascular disease were U-shaped; relationships between S-Alb and hospitalization for infection were negative linear relationships both in univariable Cox regression models and in multivariable Cox regression. Conclusions: In MHD population, there were “U-shaped” relationships between serum albumin level and mortality or hospitalization; the potential risks associated with excessive S-Alb should been taken into consideration. There was negative linear relationship between S-Alb and hospitalization for infection, S-Alb may be even more important in preventing infection in MHD population.

P1072COMPARISON OF UREMIC TOXINS, INFLAMMATORY MARKERS AND VEGF LEVEL WITH MEDIUM CUT-OFF MEMBRANES AND HIGH-FLUX MEMBRANES IN HEMODIALYSIS: THERANOVA IN SISLI HAMIDIYE ETFAL (THE SHE) STUDY

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Mustafa Sevinç ◽  
Nuri Baris Hasbal ◽  
Vuslat Yilmaz ◽  
Perin Nazif Ozcafer ◽  
Elbis Ahbap Dal ◽  
...  
Keyword(s):  
Growth Factor ◽  
Serum Albumin ◽  
Light Chain ◽  
Serum Albumin Level ◽  
Albumin Level ◽  
Uremic Toxins ◽  
High Flux ◽  
Beta 2 ◽  
Beta 2 Microglobulin ◽  
Fgf 23

Abstract Background and Aims Mortality in hemodialysis have not changed since last 30 years which may be caused by inflammation and accumulation of middle and large uremic toxins. Medium cut-off (MCO) membranes are able to perform hemodialysis as effective as hemodiafiltration. Their effect on inflammatory molecules and vascular endothelial growth factor-C (VEGF), an independent factor effective on mortality, are not well known. The aim of the study was to compare intra and inter dialyzer performances of MCO and high-flux dialyzers regarding middle and large uremic toxin, inflammatory marker, VEGF and serum albumin level. Method This is a randomized, prospective, open-label, cross-over study (ClinicalTrials.gov: NCT03836508) approved by local ethic committee. Patients had hemodialysis with either 36 sessions of high-flux dialyzer followed by 36 sessions of medium cut-off dialyzer or vice versa. Pre and postdialysis levels for urea, creatinine, albumin, total protein, free kappa light chain, free lambda light chain, beta-2 microglobulin, myoglobulin levels were determined at first and last sessions of every dialyzer. Postdialysis level of middle and large uremic molecules have been determined by a formula to prevent hemoconcentration effect. Reduction rate for uremic toxins were calculated. Serum level of human VEGF, fibroblast growth factor-23 (FGF-23), interferon gamma (IFN-g), interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-17A (IL-17A) levels were determined at first and last session of the each dialyzer. Results Fifty-two patients were enrolled to the study. Median age of patients was 56.40 (43.87-67.39) years. Median dialysis vintage was 4.77 (3.08-10.09) years. Reduction rates and postdialysis levels of free kappa and lambda light chain, myoglobulin, beta-2 microglobulin were lower both at first and last sessions in medium cut-off dialyzers compared to high-flux dialyzers (p&lt;0.05 for all) (Table 1). Last session predialysis free kappa, free lambda, beta-2 microglobulin level was lower than first session predialysis levels in medium cut-off dialyzers (p&lt;0.05 for all) (Table 2). Last session IL-6, IL-10, IL-17, IFN-gamma levels did not differ between dialyzers (p&gt;0.05 for all). Vascular endothelial growth factor levels were 500.91 (363.80-679.15) pg/ml in medium cut-off group and 610.60 (450.63-1021.93) pg/ml in high-flux group (p=0,043). Predialysis serum albumin level at first session for MCO and high-flux groups were 3.88 (3.71-4.04) g/L and 3.75 (3.59-3.95) g/L, respectively (p=0.086) (Figure 1). After 3 months of hemodialysis, it was 3.62 (3.45-3.88) g/L in MCO group and 3.78 (3.58-4.02) g/L in high-flux group (p=0.04). Serum albumin level has decreased from 3.88 (3.71-4.04) g/L to 3.62 (3.45-3.88) g/L in 3 months during hemodialysis with MCO dialyzers (p=0.0001). It did not change significantly in high-flux group in the same time period (p=0.861). Conclusion MCO membranes not only decrease post dialysis levels of free kappa, free lambda, beta-2 microglobulin, myoglobulin but also decrease the third month predialysis levels of free kappa, free lambda, beta-2 microglobulin. They do not let the increase in myoglobulin level as seen in high-flux dialyzers. Even though the IL-6, IL-10, IL-17, IFN-gamma, FGF-23 levels did not differ, VEGF levels were lower in MCO dialyzer. The most important side effect of hemodialysis with MCO membranes is decreased serum albumin level.

scholarly journals SP398MALNUTRITION RISK AND LOW SERUM ALBUMIN LEVEL IN MAINTENANCE HEMODIALYSIS PATIENTS

2018 ◽  
Vol 33 (suppl_1) ◽  
pp. i480-i481
Author(s):  
Albana Gjyzari ◽  
Alma Idrizi ◽  
Margarita Gjata ◽  
Dorina Ylli ◽  
Ilirjan Gjyzari ◽  
...  
Keyword(s):  
Serum Albumin ◽  
Serum Albumin Level ◽  
Hemodialysis Patients ◽  
Albumin Level ◽  
Maintenance Hemodialysis ◽  
Maintenance Hemodialysis Patients ◽  
Low Serum

scholarly journals MO671COMPARASION OF EXPENDED HEMODIALYSIS USING A MEDIUM CUT-OFF DIALYZER VERSUS HEMODIAFILTRATION: AN OBSERVATIONAL PROSPECTIVE STUDY

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Tijana Azasevac ◽  
Violeta Knezevic ◽  
Gordana Strazmester Majstorovic ◽  
Mira Markovic ◽  
Vladimir Veselinov ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Renal Function ◽  
Serum Albumin ◽  
Serum Albumin Level ◽  
Short Form ◽  
Liver Function Tests ◽  
Albumin Level ◽  
Uremic Toxins ◽  
Middle Molecules

Abstract Background and Aims Expended hemodialysis (HDx) with medium cut-off (MCO) membrane enables efficient depuration of middleweight uremic toxins, which play significant roles in inflammation and cardiovascular morbidity. Hemodiafiltration (HDF) is known for good removal of middle molecules but it requires more technical resources and well-functioning dialysis access. The aim of this study is to evaluate the efficacy of depuration of uremic toxins with a high-flux dialyzer during HDF session and with a MCO membrane (Theranova®) in HDx session and its impact on quality of life (QoL) in hemodialysis patients. Method In an open, single-centre, prospective observational clinical study, 28 adult stable HD patients without residual renal function were assigned to be treated by on-line HDF (HDF group) with the APS-21H dialyzer (polysulfone membrane, 2.1 m2, Asahi Kasei Medical Co., Japan) or by HDx (HDx group) with the Theranova® 400 (1.7 m2) and Theranova® 500 (2.0 m2) dialyzers (Baxter International Inc, USA). The study was conducted during 2019-2020 and completed after 12 months period. All patients were receiving maintenance high-flux membrane HDF treatment at least six months before they were enrolled in the study. Groups of patients were matched in age, sex, BMI, dialysis length and underlying disease. Complete blood count (CBC), renal function and inflammation, electrolytes, liver function tests, iron and nutritional status were evaluated at the beginning of the study and after 3, 6, 9 and 12 months. Pre and postdialysis levels for urea, creatinine, albumin, calcium, phosphorus, C-Reactive Protein, kappa and lambda free light chains (FLC), vitamin B12, β2 microglobulin levels were determined in each patient quarterly and reduction rate (RR) for uremic toxins were calculated. Furthermore single-pool Kt/V, dose of erythropoietin therapy (EPO) and vascular access were evaluated during the study, while bioimpedance analysis using Body composition monitor (Fresenius Medical Care, Germany) and QoL using SF-36 questionnaire (Kidney Disease Quality of Life Short Form-KDQOLTM-36) were evaluated at the end of observation period. The values have been reported as mean ±SD. Results There were 28 patients (14 in each group) mean age of 54.24 years (57.71±9.65 in HDx group vs 59.81±7.99 in HDF group). Median dialysis vintage was 4.77 years (5.33 in HDx group vs 6.46 in HDF group, p=0.55). Vascular access was native arteriovenous fistula in 23 patients, arteriovenous graft in 2 patients and tunnelled dialysis catheter in 3 patients (p=0.98). Kt/V was similar in both groups (1.57±0.31 vs 1.45±0.24, p=0.9), as well as weekly dose of EPO (4533.3±1922.3 vs 4233.3±1971.8, p=0.67). Patients in HDF group had a significantly higher interdialysis fluid overload (2,48±1,37 in HDx group vs 3,64±1,33 in HDF group, p=0.04), without difference in relation to the systolic and diastolic blood pressure values, as well as others BCM parameters. There were not significant differences in examined parameters of CBC, renal function and inflammation, electrolytes, liver function tests, iron and nutritional status at the beginning and at the end of the study. RR of small and middle molecules are presented in Table 1. Serum albumin level has decreased from 37.8 g/dL to 36.4 g/dL in 12 months during HDx treatment with maximal change of serum albumin level of -3.7% during that period (Figure 1). Evaluation of Kidney Disease Quality of Life Short Form at the end of study period in both groups is shown in Figure 2. Conclusion Compared to HDF, HDx with MCO membranes show greater RR for large middle molecules such as lambda FLC (45kD), while RRs for middle molecules- kappa FLC (23kD), β2 microglobulin (12kD) and small uremic toxins are similar. During one year of treatment with MCO membranes serum albumin levels remain stable. HDx treatment may improve quality of life, making an impact primarily in energy status and emotional satisfaction.

scholarly journals Low Serum Albumin Level is Risk Factor for Patients with Percutaneous Endoscopic Gastrostomy

2010 ◽  
Vol 49 (21) ◽  
pp. 2283-2288 ◽  
Author(s):  
Naoyuki Tominaga ◽  
Ryo Shimoda ◽  
Ryuichi Iwakiri ◽  
Nanae Tsuruoka ◽  
Yasuhisa Sakata ◽  
...  
Keyword(s):  
Risk Factor ◽  
Serum Albumin ◽  
Percutaneous Endoscopic Gastrostomy ◽  
Serum Albumin Level ◽  
Albumin Level ◽  
Endoscopic Gastrostomy ◽  
Low Serum
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