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Abstract: PO1061

Combining a Heparin-Grafted Dialyzer with a Citrate-Enriched Dialysate Offers Acceptable Dialysis Adequacy Avoiding Systemic Anticoagulation: Results of the Randomized Noninferiority Evocit Study

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Francois, Karlien, Vrije Universiteit Brussel, Brussels, Brussels, Belgium
  • De Clerck, Dieter, Vrije Universiteit Brussel, Brussels, Brussels, Belgium
  • Tonnelier, Annelies, Vrije Universiteit Brussel, Brussels, Brussels, Belgium
  • Cambier, Marie-Laure, Vrije Universiteit Brussel, Brussels, Brussels, Belgium
  • Cools, Wilfried, Vrije Universiteit Brussel, Brussels, Brussels, Belgium
  • Wissing, Karl Martin, Vrije Universiteit Brussel, Brussels, Brussels, Belgium
Background

The combined use of a heparin-grafted membrane with a citrate-enriched dialysate is a hemodialysis (HD) strategy with low circuit clotting rates while avoiding systemic anticoagulation. Its adequacy in comparison to HD using systemic anticoagulation is unknown.

Methods

Prevalent HD patients were recruited for a randomized crossover non-inferiority trial powered at >90% to detect a prespecified non-inferiority threshold of 10% spKt/Vurea (NCT03887468). HD using a heparin-grafted dialyzer in combination with a 1.0 mmol/L citrate-enriched dialysate (“evocit”) was compared to HD using a heparin-grafted dialyzer, systemic unfractionated heparin and bicarbonate-based dialysate (“evohep”). Each treatment arm lasted 4 weeks: 3x4hours HD/week with fixed blood and dialysate flow rates and midweek biological analyses.

Results

26 patients received 617 HD sessions: 307 evocit and 310 evohep sessions. Mean spKt/Vurea was 1.46±0.23 for evocit and 1.50±0.24 for evohep sessions (p=0.06). Mean of the paired difference in spKt/Vurea was 0.04 with a 95%CI of -0.002 to 0.08, the upper bound of the estimate lying within the prespecified non-inferiority threshold (i.e. <0.15). Urea reduction rate (RR) was 71.5±5.5% vs 72.1±5.7% and bèta2microglobulin RR 37.4±8% vs 37.8±8% for evocit and evohep sessions. Processed blood volume was 75.4±3L vs 75.8±1.5L and online Kt was 47.3±5L vs 48.3±4L for all evocit and evohep sessions. Circuit thrombosis leading to premature treatment end occurred in 13/307 (4.2%) of evocit sessions (n=6), but in none of the evohep sessions (p=0.0002), with a median 36(20-46)min treatment time shortening without impact on effective treatment times overall (236±12 vs 238±4min for evocit vs evohep). Retransfusion failure occurred in 3/307 (0.98%) of evocit sessions and none of the evohep sessions (p=0.25).

Conclusion

HD avoiding systemic anticoagulation using a heparin-grafted dialyzer with a citrate-enriched dialysate offers recommended spKt/Vurea dose and is not inferior to HD using systemic anticoagulation in terms of spKt/Vurea. Circuit clotting complications occurred at low rates during evocit sessions and did not have clinically significant repercussions on dialysis efficacy.

Funding

  • Private Foundation Support