Middle-size molecule clearance as measured by β2-microglobulin in high-flux versus low-flux dialysis and hemodiafiltration: A prospective randomized controlled trial

Abstract

Background: Whereas most studies to date have mainly concentrated on the comparison between high-flux hemodialysis (HFHD) and hemodiafiltration (HDF), or HFHD and low-flux hemodialysis (LFHD) in relation to the clearance of β2-microglobulin (β2M) in HD patients, there have been few related to combined HFHD and HDF therapy. To compare the clearance of middle-sized molecules as measured by β2M in HFHD versus LFHD and HDF.

Methods: A prospective, single-center, open-label, observer-blinded, randomized controlled trial was conducted at the West China Hospital of Sichuan University in China. Patients received either HFHD or LFHD and HDF 3 times a week with follow-ups at one and 3 months. The primary endpoint was the clearance of β2M at 3 months. The secondary endpoints included hemodialysis-related adverse events, changes in anemia, states of nutrition, and inflammatory indices.

Results: After 3 months of treatment, the HFHD+HDF group achieved a higher satisfaction level than the LFHD+HDF group, with decreased serum β2M concentrations (34.493 ± 7.257 vs. 43.593 ± 9.036 mg/L, p < 0.001) and elevated red blood cell counts (3.959 ± 0.742 vs. 3.602 ± 0.578 × 10¹² /L, p = 0.015). Compared with baseline, both kinds of treatment led to increases in serum urea (t = -3.623, p = 0.001 vs. t = -4.240, p < 0.001), cholesterol (t = -2.511, p = 0.016 vs. t = -4.472, p < 0.001), and magnesium (t = -2.648, p = 0.011 vs. t = -3.561, p = 0.001). An elevated level of serum albumin (t = -2.683, p = 0.010) was observed only in the HFHD+HDF group.

Conclusions: Combined therapy with HFHD and HDF has a beneficial effect on improving β2M clearance, red blood cell management, and nutrition status in HD patients.

Keywords: beta-2 microglobulin; clearance; hemodiafiltration; high-flux hemodialysis; low-flux hemodialysis.