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Abstract: TH-PO348

Comparison of the Removal of Uremic Toxins with Medium Cut-Off and High-Flux Dialyzers: A Randomized Clinical Trial

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Belmouaz, Mohamed, CHU POITIERS, Poitiers, France
  • Bauwens, Marc, CHU POITIERS, Poitiers, France
  • Bouteau, Iseline, CHU POITIERS, Poitiers, France
  • Thierry, Antoine, CHU POITIERS, Poitiers, France
  • Ecotiere, Laure, CHU POITIERS, Poitiers, France
  • Bridoux, Frank, CHU POITIERS, Poitiers, France
Background

Accumulation of middle weight toxins (500 Da-60 kDa) in hemodialysis (HD) patients results in increased morbidity and mortality. Conventional high-flux (HF) dialyzers allow efficient removal of beta2 microglobulin (11.8 kDa), but their effect on higher molecular weight molecules is not well established. Whether new generation of medium cut-off (MCO) dialyzer improve removal of middle to high molecular weight uremic toxins remains to be demonstrated.

Methods

Theranova, a randomized, open-label, cross-over study (NCT03211676) was designed to compare MCO-HD to HF-HD on the epuration of middle weight uremic toxins. Forty six patients treated with HF dialyzer Elisio 21H™ for more than 6 months were randomized to either continue on this membrane (n=22) or to receive the Theranova 500™ dialyzer (n=24). After 3 months, patients crossed over to the other dialyzer during 3 other months.
Primary outcome was myoglobin (17 kDa) reduction ratio (RR) at 3 months. Secondary outcomes were RR, pre and post dialysis levels of beta2 microglobulin, prolactin, hepcidin, leptin, retinol binding protein, alpha 1 glycoprotein, fibroblast growth factor-23, hyaluronic acid, homocystein and cytokines (IL6, IL1-beta, TNF-alpha) at 3 and 6 months.
Nutritional and inflammatory parameters, level of albumin and oxidative stress mediators (8-iso-Prostaglandin, oxidized LDL, superoxide dismutase), anemia parameters and erythropoietin resistance index were also determined.

Results

Forty patients completed the study. Mean age was 76 ± 9 years (male gender 74%). MCO-HD provides higher median RR of myoglobin [59% vs 36%, p<0.0001] whereas beta2 microglobulin RR was similar [77% vs 69%, p=0.7], as compared to HF-HD.
Mean pre-dialysis beta2 microglobulin levels [26.9 mg/l vs 28.4 mg/l, p =0.001] and post dialysis myoglobin levels [76 μg/l vs 126 μg/l, p<0.0001] were significantly lower with MCO-HD. Pre and post dialysis albumin levels were significantly lower with MCO-HD [36.9 g/l vs 38.2 g/l, p=0.004] and [40 g/l vs 42.3 g/l, p=0.004].

Conclusion

These preliminary data indicate that MCO-HD provides significant removal of myoglobin and decrease in beta2 microglobulin pre dialysis level, with higher albumin loss than HF-HD. Complete results will be presented during the meeting.

Funding

  • Commercial Support