Impact of Medium Cut-Off Dialyzers on Patient-Reported Outcomes: COREXH Registry

Abstract

<b><i>Introduction:</i></b> A new generation of hemodialysis (HD) membranes called medium cut-off (MCO) membranes possesses enhanced capacities for middle molecule clearance, which have been associated with adverse outcomes in this population. These improvements could potentially positively impact patient-reported outcomes (PROs). <b><i>Objective:</i></b> The objective of this study was to evaluate the impact of MCO membranes on PROs in a cohort of HD patients in Colombia. <b><i>Methods:</i></b> This was a prospective, multicenter, observational cohort study of 992 patients from 12 renal clinics in Colombia who were switched from high-flux HD to MCO therapy and observed for 12 months. Changes in Kidney Disease Quality of Life 36-Item Short Form Survey (KDQoL-SF36) domains, Dialysis Symptom Index (DSI), and restless legs syndrome (RLS) 12 months after switching to MCO membranes were compared with time on high-flux membranes. Repeated measures of ANOVA were used to evaluate changes in KDQoL-SF36 scores; severity scoring was used to assess DSI changes over time; Cochran’s Q test was used to evaluate changes in frequency of diagnostic criteria of RLS. <b><i>Results:</i></b> During 12 months of follow-up, 3 of 5 KDQoL-SF36 domains improved compared with baseline: symptoms (<i>p</i> < 0.0001), effects of kidney disease (<i>p</i> < 0.0001), and burden of kidney disease (<i>p</i> < 0.001). The proportion of patients diagnosed with RLS significantly decreased from 22.1% at baseline to 10% at 12 months (<i>p</i> < 0.0001). No significant differences in the number of symptoms (DSI, <i>p =</i> 0.1) were observed, although their severity decreased (<i>p</i> = 0.009). <b><i>Conclusions:</i></b> In conventional HD patients, the expanded clearance of large middle molecules with MCO-HD membranes was associated with higher health-related quality of life scores and a decrease in the prevalence of RLS.

Impact of Expanded Hemodialysis Using Medium Cut-off Dialyzer on Quality of Life: Application of Dynamic Patient-Reported Outcome Measurement Tool

“…Upon return to high-flux HD, the loss-of-effect and return to baseline appeared to be very similar in terms of delayed onset of effect, although further investigation is required. This is in keeping with a putative clearance-based explanation of symptom improvement with HDx therapy (16,19).…”

“…Recent studies using pre-existing cross-sectional PROM tools for CKD report that HDx therapy also has a positive impact on HR-QoL, improving physical function, reducing the severity, frequency of symptoms and disease burden. (16,19) To date however, there is no available information on the onset-timing, scale or durability of effect of HDx therapy on HR-QoL. Additionally, there has been no direct interrogation into the characteristics of populations that may benefit from HDx therapy to assist in clinical decision making and resource allocation.…”

“…Patient reported outcome measures (PROM) provide information relating to the patient's subjective experience of disease and treatment and can be important in supporting and evaluating healthcare quality and decision making (18)(19)(20)(21)(22). Traditionally, PROM specific to CKD patients are largely used to provide cross-sectional assessment, have long recall periods (two-four weeks), and are not intended to be used repeatedly.…”

Expanded Haemodialysis as a Current Strategy to Remove Uremic Toxins

“…Until now, 5 studies have been conducted comparing QOL in HDx compared with HD (Table 4). In 2 studies there were no differences in the self-reported patient outcomes [13,14], whereas in 3 others an improvement in the physical domains of QOL and uremic pruritus [12], in the Restless Legs Score (RLS) and an association with higher health-related quality of life scores [55], and in KDQoL-SF36 survey [16] were reported. Except for the study by Alarcon et al, all others measured the MM removal, finding a significant clearance of some MM with HDx, but a relationship between the better MM removal and change in QOL still need a deep evaluation and adequate powered clinical trials.…”

Hemodiálisis extendida frente a convencional o hemodiafiltración en línea. Estudio comparativo de necesidad de heparina y coagulación del sistema

“…Las técnicas de diálisis actuales tienen limitaciones para eliminar de forma adecuada los solutos urémicos de gran peso molecular [5][6][7] . Moléculas de hasta 25 kDa pueden ser eliminadas por difusión, mientras que las moléculas medias superiores a los 25 kDa precisan de un trasporte convectivo o el uso de membranas altamente permeables para ser eliminadas 1,8 .…”