#648 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

Résumé fourni par la source

Abstract Background and Aims Medium cut-off hemodialysis (MCO-HD) improves removal of middle molecules (MM) uremic toxins. The effects of the novel vitamin E-coated super high-flux (SHFVE) dialyzer on MM removal and biocompatibility parameters including inflammation and oxidative stress remain to be investigated. Method This non-inferiority cross-over prospective randomized study (NCT05610683) included 36 patients randomly assigned to receive either 3 months of MCO-HD followed by 3 months of SHFVE-HD, or vice-versa. At 3 months from randomization, each patient underwent a two-week High-flux hemodialysis washout period. The primary endpoint was beta2-microglobulin reduction ratio (RR) after 3 months. Secondary endpoints were other MM RR and biocompatibility parameters. Results Compared to MCO-HD, SHFVE-HD provided a non-inferior beta2-microglobulin RR: 74% [CI 95%: 71;77] versus 73% [CI 95%: 71;76] with a difference of 0.9% [CI 95%: −1.9%; 3.6] and similar mean RR of prolactin, alpha1-microglobulin, vascular endothelial growth factor, kappa and lambda free light chains. Although MCO-HD resulted in a higher mean myoglobin RR compared to SHFVE-HD (60 ± 6.6 vs 55 ± 7.3%, P = 0.022), SHFVE-HD was associated with a non-significant trend towards lower myoglobin pre-dialysis levels (P = 0.08). Median pre-dialysis levels of interleukin 6 (0.8 [0–4.4] vs (1.7 [0.2–7.2] pg/ml, P = 0.032), asymmetric dimethylarginine (ADMA) (163 [122–260] vs 167 [133–270] ng/ml, P = 0.01], mean pre-dialysis soluble tumor necrosis factor receptor 1 (sTNFR1) levels (12.7 ± 3.5 vs 13.6 ± 3.6 ng/ml, P = 0.039) and mean post-dialysis oxidized low density lipoprotein (LDL) levels (54 ± 18 vs 63 ± 22 ng/ml, P = 0.01) decreased significantly with SHFVE-HD. SHFVE-HD induced a significantly lower mean RR in blood leucocyte count 15 min after dialysis initiation (2.3 ± 7 vs 8.4 ± 11%, P = 0.009). This leucocyte fluctuation encompassed both polymorphonuclear neutrophils and monocytes. Conclusion Compared to MCO-HD, SHFVE-HD appears to provide similar MM RR and may be associated with improved biocompatibility parameters.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.