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Abstract: TH-PO0886

A Novel Medium Cut-Off Hemodialysis Membrane for Removal of an Extended Spectrum of Uremic Toxins

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Herzog, Anna Laura, University Hospital of Würzburg, Nephrology, Würzburg, Germany
  • Krieter, Detlef H., University Hospital of Würzburg, Nephrology, Würzburg, Germany
  • Hofmann, Kirsten, University Hospital of Würzburg, Nephrology, Würzburg, Germany
  • Brüchmann, Jule, University Hospital of Würzburg, Nephrology, Würzburg, Germany
  • Wanner, Christoph, University Hospital of Würzburg, Nephrology, Würzburg, Germany
Background

The removal of a broad spectrum of uremic toxins and inflammatory mediators during extracorporeal dialysis therapy is considered beneficial for improved outcomes in patients with acute and end-stage kidney disease. Aim of the present investigation was to characterize the pre-clinical and clinical performance of a newly developed medium-cut-off membrane for improved elimination of an extended spectrum of solutes in hemodialysis.

Methods

To demonstrate the sieving properties and biocompatibility of a new polyethersulfone membrane in e-beam-sterilized dialyzers, pre-clinical in vitro tests were conducted in accordance with EN ISO 8637-1: 2017 and 10993-4: 2017 using Baxter Theranova as a reference dialyzer. In a subsequent clinical pilot study, the removal of a broad spectrum of small (urea 60 Da, PO4 96 Da) and middle molecular solutes (b2M, 11.8 kDa; myoglobin (myo), 17.6 kDa; interleukin 6 (IL6), 21-26 kDa; free k and l light chains (kFLC, lFLC), 22.5 and 45 kDA, resp.) as well as the albumin loss into dialysate (67 kDa) during hemodialysis was measured.

Results

Compared to a Theranova reference dialyzer, in vitro tests showed a steeper sieving coefficient curve and lower activation of leukocytes, platelets and complement C5a by the new membrane. Thrombin-anti-thrombin-III generation was acceptable. A total of 12 patients (5 male/7 female; 67.1 ± 11.2 years; 82.7 ± 30.0 kg) were enrolled in the clinical study. Compared to a previous clinical trial with Theranova, the new membrane had higher instantaneous plasma clearances for PO4 (202 ± 26 vs. 187 ± 9 mL/min), b2M (112 ± 15 vs. 79 ± 7 mL/min), kFLC (48 ± 20 vs. 36 ± 7 mL/min) and lFLC (17 ± 14 vs. 7 ± 9 mL/min). Since the patients' weight differed greatly (Theranova 74.1 ± 14.5 kg), most reduction ratios in the present study were lower. The albumin loss exceeded that of Theranova (2.1 ± 2.0 g) at 4.2 ± 2.0 g.

Conclusion

The new dialysis membrane demonstrated excellent in vitro biocompatibility and highly efficient removal of a broad spectrum of middle molecular solutes at acceptable albumin loss in hemodialysis. It represents a promising advancement in existing dialysis membrane technologies.

Funding

  • Government Support – Non-U.S.