Archive | 2021
Expanded Hemodialysis as Effective Alternative to On-Line Hemodiafiltration: A Randomized Mid-Term Clinical Trial
Abstract
\n BACKGROUND.\n\nHemodiafiltration (HDF) enhances middle molecule (MM) removal by convection and shows survival benefit compared to high-flux hemodialysis. Expanded hemodialysis (HDx), a novel therapy that effectively clears MM, uses medium cut-off (MCO) membrane without need for replacement fluid. We aimed to compare HDx to HDF prospectively in an open randomized controlled clinical study.\nMETHODS.\n\nIn a 24-week prospective study, HDF patients (age 18–80 yrs; on HDF\u2009>\u20093 months) were randomized to switch to HDx (N\u2009=\u200921) or continue HDF (N\u2009=\u200922). Pre- to post-dialysis reduction ratios (RR) and changes in pre-dialysis levels over time were evaluated for MMs and other clinical biomarkers. Use of erythropoiesis-stimulating agents (ESAs) were evaluated.\nRESULTS.\n\nHDx showed greater RR for YKL-40 while RR appeared similar between groups for beta2-microglobulin, FGF-23, and free light chains. Intra-dialytic changes in inflammatory biomarkers (IL-6, CRP, PTX3) did not differ between therapies. Changes from baseline to 12 and 24 weeks did not differ between groups for MMs, inflammatory markers, albumin, fibrinogen, hemoglobin, PTH, and phosphorus. Usage of erythropoiesis-stimulating agents tended to decrease in HDx arm while remaining stable in HDF arm.\nCONCLUSIONS.\n\nHDx showed equivalent removal of MMs versus high volume HDF. Greater RR of YKL-40, predictor of cardiovascular mortality in HD, was noted in HDx group. HDx appeared safe with similar clinical effectiveness as HDF. With fewer requirements and resource needs, HDx provides an attractive alternative to HDF. Further clinical studies are needed to confirm our results.\nTRIAL REGISTRATION.\n The study was registered as NCT03499691