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Abstract: PO0793

Real-World Clinical Performance Evaluation of the FX CorAL Dialyzer: A Retrospective Cohort Study

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Wolf, Melanie, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
  • Zhang, Hanjie, Renal Research Institute, New York, New York, United States
  • Winter, Anke, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
  • Stauss-Grabo, Manuela, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
  • Ponce, Pedro, Nephrocare Portugal SA, Lisboa, Lisboa, Portugal
  • Ladanyi, Erzsebet, NephroCare Hungary, Miskolc, Hungary
  • Arkossy, Otto, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
  • Kotanko, Peter, Renal Research Institute, New York, New York, United States
  • Stuard, Stefano, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
Background

In-vitro dialyzer clearances as outlined in the Instructions for Use may not necessarily reflect clinical reality. Clinically, the in-vivo dialyzer performance is more relevant. Thus, we evaluated the clinical performance of two dialyzers (FX CorDiax, FX CorAL) with slightly different in-vitro clearances.

Methods

18 Hungarian and 33 Portuguese NephroCare Dialysis centers were randomly allocated to an implementation scheme. European Clinical Database data from 1,924 adult patients who switched from the FX CorDiax to the FX CorAL dialyzer between July 2020 and January 2021 were analyzed. To evaluate the clinical performance, we compared intra-individual changes of various parameters between 3 months before and 3 months after the dialyzer switch using paired t-test or Wilcoxon signed-rank test.

Results

The patients median age was 70 years, 64.2% were male, 38.4% had diabetes and 63.3% hypertension. The median dialysis vintage was 55.1 months. 88.6% of treatments were performed with online hemodiafiltration (HDF); 75.3% of patients had a fistula.
After the dialyzer switch, the online clearance monitor Kt/V increased by 0.05 (2.7%). Among HDF patients, the effective infusion and convective volume increased by about 0.5 l and the effective treatment time increased by 4.2 min (1.8%). All mean changes were statistical significant (Table 1).

Conclusion

In this analysis of real-world FX CorAL dialyzer utilization, we observed statistically significant changes in performance parameters. In contrast to in-vitro results, our data suggest that the clinical performance of the FX CorAL and FX CorDiax dialyzer is comparable.

Table 1: Overall mean change after switch versus before switch
ParamterMean before (SD)Mean diff [95%-CI]Paired t-test / Wilcoxon
Effective treatment time [min]235.06 (18.73)4.21 [3.80; 4.63]<.0001
Mean blood flow [ml/min]399.43 (48.49)-0.58 [-1.45; 0.30]<.0001
Dialysate flow [ml/min]420.33 (56.18)-2.41 [-3.37; -1.45]<.0001
Effective infusion (HDF) [l]23.18 (4.56)0.48 [0.37; 0.59]<.0001
Convective volume (HDF) [l]25.33 (4.53)0.54 [0.44; 0.65]<.0001
Single-Pool Variable-Volume Kt/V1.94 (0.33)0.09 [0.07; 0.11]<.0001
Urea reduction ratio [%]79.93 (5.24)1.29 [0.96; 1.63]<.0001
Equilibrated Kt/V1.66 (0.29)0.09 [0.07; 0.11]<.0001
Online Clearance Monitoring Kt/V1.80 (0.39)0.05 [0.04; 0.06]<.0001

Funding

  • Commercial Support