Effects of super high-flux vitamin E–coated and medium cut-off dialyzers on uremic toxins removal and biocompatibility: the E-FLUX randomized controlled study

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ABSTRACT Background Medium cut-off hemodialysis (MCO-HD) improves removal of middle molecules (MM) uremic toxins. The effects of the novel super high-flux vitamin E–coated (SHFVE) dialyzer on MM removal and biocompatibility parameters including inflammation and oxidative stress remain to be investigated. Methods This non-inferiority cross-over prospective randomized study included 36 patients randomly assigned to receive either 3 months of MCO-HD followed by 3 months of SHFVE-HD, or vice versa. The primary endpoint was beta2-microglobulin reduction ratio (RR) after 3 months. Secondary endpoints were other MM RR and biocompatibility parameters. Results SHFVE-HD provided non-inferior beta2-microglobulin RR as compared with MCO-HD {74.2% [95% confidence interval (CI) 71; 77] vs 73.3% (95% CI 71; 76) with a difference of 0.9% (95% CI –1.9%; 3.6), respectively}, with similar mean RR of prolactin, alpha1-microglobulin, vascular endothelial growth factor, and kappa and lambda free light chains. SHFVE-HD induced lower mean myoglobin RR compared with MCO-HD (55.5 ± 7.3 vs 60.2 ± 6.6%, P = 0.022). Myoglobin pre-dialysis levels were not significantly different [160 (118–199) vs 167 (167–240) µg/L, P = .08]. Median pre-dialysis levels of interleukin-6 [0.8 (0–4.4) vs 1.7 (0.2–7.2) pg/mL, P = .032], asymmetric dimethylarginine (ADMA) [163 (122–260) vs 167 (133–270) ng/mL, P = .01), mean pre-dialysis serum soluble tumor necrosis factor receptor 1 (sTNFR1) levels (12.7 ± 3.5 vs 13.6 ± 3.6 ng/mL, P = .039) and mean post-dialysis oxidized low-density lipoprotein levels (54 ± 18 vs 63 ± 22 ng/mL, P = .01) decreased significantly with SHFVE-HD. SHFVE-HD induced a significantly lower median relative variation in blood leucocyte count 15 min after dialysis initiation [–3.5 (–6.8 to 1.6) vs –6.2 (–12.9 to –1.5) %, P = .009], encompassing both polymorphonuclear neutrophils and monocytes. Conclusion Compared with MCO-HD, SHFVE-HD appears to provide similar MM RR and may be associated with improved biocompatibility parameters. Trial registration: ClinicalTrials.gov NCT05610683. Data deposited at Centre de la recherche clinique CHU Poitiers

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