Clinical evaluation of the Prismaflex™ HF 20 set and Prismaflex™ system 7.10 for acute continuous kidney replacement therapy (CKRT) in children

Pediatr Nephrol. 2020 Dec;35(12):2345-2352. doi: 10.1007/s00467-020-04664-7. Epub 2020 Jun 30.

Abstract

Background: Continuous kidney replacement therapy (CKRT) is a common modality for treatment of severe acute kidney injury (AKI) in children. Adult technologies routinely utilized to provide this therapy have a large extracorporeal volume. The Prismaflex™ HF20 filter set has a relatively low extracorporeal blood volume of 60 mL, which provides technological benefit for smaller children compared with current filter sets available in the USA.

Methods: We conducted a multicenter, open-label single group study to evaluate whether the Prismaflex™ HF20 filter set delivers efficacious and safe CKRT to support patients with AKI, fluid overload, or both in pediatric patients weighing ≥ 8 to 20 kg.

Results: Twenty-three patients were enrolled between April 24, 2016 and April 8, 2018. The mean reduction in blood urea nitrogen from baseline to 24 h was 58.12 ± 20.08% (95% CI, - 68.45 and - 47.79 (p = 0.0008)). Median cumulative normalized effluent rate at 24 h was 60.8 mL/kg/h (25.9, 83.7). None of the patients participating in the study suffered a serious adverse event; thus, no obvious safety concerns were noted.

Conclusions: We suggest that the Prismaflex HF20™ filter set used in conjunction with the Prismaflex™ System Software Version 7.10 or 7.20 is a suitable alternative to larger filter sets for use in pediatric patients weighing less than 20 kg. Graphical abstract.

Keywords: Acute kidney injury; CKRT; HF20; Kidney replacement therapy; Pediatric dialysis; Prismaflex.

Publication types

  • Evaluation Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Kidney Injury / therapy*
  • Blood Urea Nitrogen
  • Child
  • Child, Preschool
  • Continuous Renal Replacement Therapy / adverse effects
  • Continuous Renal Replacement Therapy / instrumentation*
  • Creatinine / blood
  • Female
  • Humans
  • Male
  • Prospective Studies

Substances

  • Creatinine