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1.
Int J Artif Organs ; 47(4): 260-268, 2024 Apr.
Article En | MEDLINE | ID: mdl-38456311

BACKGROUND: Middle uremic toxins (MUTs) can cause anemia and erythropoietin hyporesponsiveness. Theranova dialyzers may improve anemia management by removing MUTs. Hence, the impact of Theranova dialyzers on erythropoietin responsiveness was studied. METHODS: This exploratory single-center prospective observational study, encompassing 50 patients undergoing dialysis with either the Theranova-400 or FX80 membrane for 6 months, involved monthly tracking of hemoglobin levels, weight-adjusted erythropoiesis-stimulating agent (w-ESA) dosing, and erythropoietin resistance index (ERI), with ESA treatment decisions guided by a proprietary algorithm. RESULTS: The groups were similar in terms of demographics and baseline laboratory test results. The median hemoglobin levels, w-ESA and ERI, were found to be similar between FX80 and Theranova-400 groups at both baseline (11.06 vs 10.57, p = 0.808; 92.3 vs 105.2, p = 0.838; 8.1 vs 10.48, p = 0.876) and the end of the study (11.43 vs 11.03, p = 0.076; 48.7 vs 71.5; 4.48 vs 6.41, p = 0.310), respectively. There was a trend toward lower w-ESA and ERI at the end of the study compared to baseline in both groups, but the difference was non-significant. CONCLUSIONS: Based on this study of 50 patients undergoing high-flux dialysis with near-target hemoglobin levels, switching to Theranova 400 dialyzers compared to FX80 dialyzers did not show statistically significant differences in maintaining hemoglobin levels, reducing ESA dose, or lowering ERI. The non-randomized design and small sample size limit the study's power to detect true differences. Larger, randomized trials are needed to confirm findings and definitively assess Theranova 400's benefits.


Anemia , Hematinics , Hemoglobins , Renal Dialysis , Humans , Renal Dialysis/adverse effects , Male , Female , Prospective Studies , Anemia/blood , Anemia/drug therapy , Anemia/diagnosis , Anemia/etiology , Anemia/therapy , Middle Aged , Hematinics/therapeutic use , Hematinics/administration & dosage , Hemoglobins/metabolism , Aged , Erythropoietin/therapeutic use , Membranes, Artificial , Treatment Outcome , Adult
2.
Blood Purif ; 53(3): 219-228, 2024.
Article En | MEDLINE | ID: mdl-38142670

INTRODUCTION: Medium cut-off (MCO) membranes may be able to remove middle-large uremic toxins that are retained in the body, which has been linked to various risk factors including malnutrition-inflammation score (MIS). The effect of MCO dialyzers on MIS has been studied. METHODS: This single-center exploratory prospective observational study enrolled maintenance hemodialysis patients who underwent dialysis using either MCO (Theranova 400) or high-flux (FX80) membranes as part of their regular care. Measurements of MIS, body weight, height, body mass index, and various biochemical markers were taken at the beginning and conclusion of the study. RESULTS: This study included 50 patients who were treated with either the Theranova 400 (n = 25) or the FX80 (n = 25) for a period of 6 months. The two groups were similar in terms of demographics, duration of hemodialysis treatment, and baseline biochemical test results. Theranova 400 had no significant impact on the median MIS (6 [6-10] vs. 7 [5-10], p 0.575) and serum albumin levels (4.07 [3.92-4.22] vs. 4.04 [3.85-4.30], p 0.689), while the FX80 resulted in a significant increase in MIS (6 [5-8] vs. 8 [6-10], p 0.033) and a significant decrease in serum albumin levels (4.23 [4.03-4.36] vs. 3.98 [3.77-4.12], p 0.027) at the end of the study. DISCUSSION/CONCLUSION: After 6 months of treatment, the MCO dialyzer did not demonstrate a statistically significant difference in the MIS when compared to the high-flux dialyzer. However, MIS worsening was significantly less in the MCO group, indicating the potential benefits of MCO membranes in maintaining nutritional status. Further research is required to validate these results.


Cephalosporins , Malnutrition , Renal Dialysis , Humans , Renal Dialysis/adverse effects , Renal Dialysis/methods , Inflammation/etiology , Malnutrition/etiology , Malnutrition/therapy , Serum Albumin
3.
Ther Apher Dial ; 23(4): 328-335, 2019 Aug.
Article En | MEDLINE | ID: mdl-30447048

Weak evidence is present for choosing amongst different temporary hemodialysis catheter (THC) designs with regards to the risk of venous thrombosis, therefore two THC designs for the right internal jugular vein (RIJV) were compared. Patients aged ≥18 years who needed THC insertion into the RIJV for acute hemodialysis due to either acute or chronic renal failure were included. The type of THC (precurved/straight) was dependent on the date of hospital admission. Clinical and ultrasonographic surveillance was conducted prospectively. Thrombosis of the RIJV was the primary objective. Precurved and straight catheters were inserted into 32 and 23 patients (mean age 63 ± 15 years, females 28), respectively. The baseline characteristics and catheter dwell-times were similar in both groups. Partial and total thrombosis of the RIJV during catheter dwell-time developed at a higher rate in the straight group (52% vs. 9.3%, P = 0.000; 47.8% vs. 9.3%, P = 0.001, respectively). At least 2 weeks after catheter removal, total thrombosis was found in 43.4% vs. 9.6% (P = 0.004) of patients with straight and precurved THCs, respectively. The hazard ratios for total thrombosis was 0.161 (P = 0.006) during catheter dwell-time and 0.190 (P = 0.012) after catheter removal. Catheter dysfunction did not occur and only one catheter-related bloodstream infection (CRBI) was seen. Thrombosis rates of the RIJV were higher with straight vs. precurved THCs, both during catheter dwell-time and after catheter removal. Catheter dysfunction was not noted in any group and the rate of CRBI was extremely low.


Catheter-Related Infections , Catheterization, Central Venous , Jugular Veins , Renal Dialysis/instrumentation , Renal Insufficiency/therapy , Thrombosis , Catheter-Related Infections/diagnosis , Catheter-Related Infections/etiology , Catheter-Related Infections/prevention & control , Catheterization, Central Venous/adverse effects , Catheterization, Central Venous/instrumentation , Catheterization, Central Venous/methods , Comparative Effectiveness Research , Equipment Design , Female , Humans , Male , Middle Aged , Outcome and Process Assessment, Health Care , Renal Dialysis/adverse effects , Renal Dialysis/methods , Risk Factors , Thrombosis/diagnosis , Thrombosis/etiology , Thrombosis/prevention & control , Turkey , Vascular Access Devices/adverse effects , Vascular Access Devices/standards
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