SP464
Medium Cut-Off (Theranova®) dialyzer reduces the number of infections in hemodialysis patients: a prospective, cross-over study Free

INTRODUCTION: Despite hemodialysis has been going through significant improvements during the last decades, leading to longer survival and better quality of life in patients with end-stage renal disease, current dialysis techniques still have important limitations in adequately removing some of the uremic solutes such as middle molecules and protein-bound uremic toxins. The retention of middle molecules is associated with the development of cardiovascular disease, chronic inflammatory disease, CKD-MBD, secondary immunodeficiency, amyloidosis and protein-energy wasting. Although the removal of these toxins can be achieved with online HDF, the use of this technique is limited by the need for high blood flows and accurate monitoring devices. Also the treatment with of HCO membranes provides a good clearance of middle molecules but it is also associated with protein loss, and its chronic use leads to hypoalbuminemia. Instead, the new MCO membrane provides diffusive removal of solutes with medium to large MW up to 45 kD, with only marginal albumin leak. The application of MCO membranes in clinical dialysis is called “expanded hemodialysis” (HDx).

METHODS: The aim of this prospective, open-label, controlled, crosso-ver pilot study, was to compare HDx (with the new MCO membrane Theranova® 400) and conventional HD in 20 prevalent hemodialysis patients, based on hematochemical values, parameters of dialysis adequacy, incidence of adverse events, incidence of infections, number and causes of hospitalization. We divided the study in 2 phases; within the first one, we assigned 10 patients to undergo conventional HD high-flux dialyzer, and the other 10 patients to undergo HDx for 3 months. Later, during the second phase, the same patients were switched to receive HDx and HD.

RESULTS: The treatment with HDx was associated with the lowering of albumin concentration (median reduction –0,45 g/dL [-0,575 / -0,05], p=0,025). However, this reduction did not appear to be clinically relevant. In fact median values of albuminemia were ≥3,5 g/dL and none of the patients had clinical symptoms of hypoalbuminemia or needed intravenous administration of albumin. The total number of infections (presence of signs and symptoms treated with antibiotic therapy) was lower in patients treated with HDx (7) than in patients treated with HD (18). Interestingly, patients tretaed with HDx had reduced levels of IL-6 (6.45 ± 1.57 pg/ml) compared to HD (9.48 ± 2.15 pg/ml) and of IL-1beta (from 0.06 ± 0.02 pg/ml with HDx to 0.28 ± 0.18 pg/ml with HD), while TNFalpha did not change.

CONCLUSIONS: According to this pilot study, the chronic use of the new medium cut off dialyzer Theranova® appears to be safe and tolerable, not causing any serious side effects and neither hypoalbuminemia. Besides, the treatment with HDx seems to be associated to a lower incidence of infectious diseases. These associations need to be confirmed in larger randomized clinical trials.