Randomized controlled trial of medium cut-off versus high-flux dialyzers on quality of life outcomes in maintenance hemodialysis patients

Abstract

Medium cutoff (MCO) dialyzers help remove larger middle molecules associated with symptoms related to the accumulation of uremic retention solutes. We investigated the effect of an MCO dialyzer on the improvement of quality of life (QOL) in maintenance hemodialysis (HD) patients. Forty-nine HD patients with high-flux dialysis were randomly assigned to either an MCO (Theranova 400, Baxter) or a high-flux (FX CorDiax 80 or 60, Fresenius Medical Care) dialyzer and completed the study. QOL was assessed at baseline and after 12 weeks of treatment using the Kidney Disease Quality of Life Short Form-36, and pruritus was assessed using a questionnaire and visual analog scale. The reduction ratios of middle molecules were also evaluated. Laboratory markers, including serum albumin, did not differ between the two groups after 12 weeks. Removals of kappa and lambda free light chains were greater for MCO dialyzer than high-flux dialyzer. The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively). MCO dialyzers may improve patientreported outcomes, particularly the physical components of QOL and uremic pruritus, in patients with high-flux dialyzers. Patients on maintenance dialysis suffer variable symptoms such as fatigue, generalized weakness, and pruritus. These subjective conditions are assumed to be related to middle molecules that are not cleared by conventional hemodialysis (HD) 1. Middle molecules have molecular weights (MWs) ranging between 500 and 60,000 daltons, and their size is a barrier to removal with dialyzers 2,3. The accumulation of middle molecules is associated with specific complications such as amyloidosis, inflammatory reactions, oxidative stress, and endothelial dysfunction 3-5. Consequently, middle molecules contribute to morbidity and mortality and poor quality of life (QOL) in end-stage renal disease (ESRD) patients 6,7. High-flux dialysis, which has benefits for middle molecule clearance, has not displayed a clear mortality advantage compared with low-flux dialysis; the survival benefits of high-flux dialysis were only observed in patients with hypoalbuminemia and diabetes 8,9. Another dialytic modality, hemodiafiltration (HDF) with increased convection, has a higher efficiency for reducing middle-sized solutes than high-flux dialysis 10,11. Large randomized trials comparing HDF and high-flux dialysis have shown conflicting patient outcome results 12-15 ; however, recent results have consistently shown that HDF with a high convection volume improves patient survival 16-18. Medium cutoff (MCO) dialyzers are characterized by a more even distribution of larger pore sizes and a higher number of pores. MCO dialyzers have a higher permeability and...

Slipping Through the Pores: Hypoalbuminemia and Albumin Loss During Hemodialysis

“…In a recent trial of 50 patients randomized to receive 12 weeks of HD with an MCO dialyzer (Theranova 400) or with a high flux (FX CorDiax 60 or 80) dialyzer, serum albumin levels decreased by a mean (SD) of 0.13 (0.23) g/l in the MCO group. 69 There was a 0.02 g/dl mean decrease in albumin levels among patients receiving HD with the high flux dialyzer. In a separate randomized, prospective, open-label, crossover study, 3 months of HD with MCO dialyzers (Theranova 500) resulted in significant decreases in pre-dialysis serum albumin levels.…”

Medium cut-off dialyzer improves erythropoiesis stimulating agent resistance in a hepcidin-independent manner in maintenance hemodialysis patients: results from a randomized controlled trial

“…RR of serum hepcidin and TNF-α was calculated using pre-to-post-dialysis serum concentration, and the Bergstrom and Wehle formula 53 was used to compensate the hemoconcentration during HD. The detailed calculation method has been shown in our previous study 46 .…”

“…This is a post-hoc analysis of the prospective, randomized, controlled, open-label trial to compare the ESA resistance between MCO and high-flux HD patients. The original randomized controlled trial was designed to evaluate the effectiveness of MCO dialyzer on quality of life compared to high-flux dialyzer 46 . Chronic maintenance HD patients treated with high-flux dialyzer at the Kyungpook National University Hospital were enrolled from July 2018 and followed up for 12 weeks; the study ended in January 2019.…”

“…Chronic maintenance HD patients treated with high-flux dialyzer at the Kyungpook National University Hospital were enrolled from July 2018 and followed up for 12 weeks; the study ended in January 2019. The trial was registered with the Clinical Research Information Service (CRiS) at the Korea Centers for Disease Control and Prevention (KCT0003026; registration date: 25/07/2018), and detailed information regarding the inclusion and exclusion criteria are provided in our previous study 46 and CRiS website ( https://cris.nih.go.kr ).…”

Changes in plasma sclerostin level associated with use of a medium cut-off dialyzer in end-stage renal disease

“…However, there are few long-term studies regarding change in plasma levels of larger middle molecules using the MCO membrane. Moreover, most clinical studies have focused on the clinical effects of the MCO membrane for only larger middle molecules, such as proinflammatory cytokines (TNF-α and ILs) and kappa or lambda free light chains (κFLC or λFLC) [6][7][8][9]. Additionally, cardiovascular changes in patients with ESRD undergoing maintenance hemodialysis (HD) mainly present with fluid overload, uremic cardiomyopathy, and ischemic heart disease; these clinical changes are associated with secondary hyperparathyroidism, anemia, inter-dialytic weight gain, and uremic toxin accumulation.…”