Eficacia dialítica y clínica de la hemodiálisis extendida en comparación con la hemodiafiltración en línea

Abstract

Background: The medium cut-off membranes (MCO), are a new high-flow dialysis membranes, with special design and high sieving coefficient for middle molecules (MM), which allow a new hemodialysis (HD) therapy, expanded HD (HDx). Post-dilutional on-line HDF (OLHDF) is now considered the HD therapy of choice for its proven long-term benefits. To date, there are very few studies on HDx related to OLHDF in routine clinical practice. So, we have proposed this study with the primary objective of evaluating the efficacy of HDx compared to OLHDF. Methods. Observational clinical trial, randomized by residual diuresis, patients between 18-80 years old, on OLHDF at least 3 months before the start of the study. Two arms were formed, the HDx arm (n = 21) and the OLHDF control arm (n = 22) with a 24-week follow-up. Week 12 of the study evaluated the percentage reduction (RR) of beta-2 microglobulin (β2m), kappa free light chains (CLL-κ), fibroblast growth factor 23 (FGF-23), chitinase 3-like 1 (YKL-40) and lambda free light chains (CLL-λ); and inflammatory markers, interleukin-6 (IL-6), interleukin-10 (IL-10), C-reactive protein (hsCRP) and pentraxin 3 (PTX-3). In addition, the pre-dialysis levels of these molecules and hematocrit, creatinine, urea, ions, albumin, bone-mineral metabolism parameters, and iron were evaluated at weeks 12 and 24. Quality of life was also assessed using the KDQOL-36 questionnaire and the dialysis symptom index (DSI). Results: HDx demonstrated a significantly higher RR for YKL-40 (p<0.001) while the RR of β2m, CLL-κ, FGF-23 and CLL-λ were comparable to those of the control group. The RRs of inflammatory markers (IL-6, IL-10, us-PRC, and PTX-3) were similar in both groups. Pre-dialysis plasma levels at week 12 did not differ significantly between the two therapies for MM, inflammatory markers, hematocrit, creatinine, urea, ions, albumin, bone-mineral metabolism, or iron metabolism parameters; while, at week 24, the pre-dialysis levels of β2m and FGF-23 were significantly lower in HDx (p<0.05), and the rest of the molecules were similar between both groups. The use of erythropoiesis-stimulating agents tended to decrease in the HDx arm while remaining stable in the control group. The 5 subscales of the KDQOL-36 questionnaire and the DSI were comparable between both groups. Conclusions: HDx shows similar performance in removing MM and inflammatory markers compared to OLHDF, better RR for YKL-40, and lower pre-dialysis β2m and FGF-23 levels with optimal dialysis dose. It is a safe and well-tolerated dialysis therapy with side effects comparable to OLHDF, and pre-dialysis albumin levels in the normal range. HDx maintains quality of life parameters comparable to OLHDF at 6-month follow-up.