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

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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.

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Acknowledgments

Patrick D. Brophy, University of Iowa Stead Family Children’s Hospital, Iowa City, IA; Dawn Eding, Helen DeVos Children’s Hospital, Grand Rapids, MI; Jennifer Ehrlich, University of Iowa Stead Family Children’s Hospital, Iowa City, IA; Emily Gleason, Helen DeVos Children’s Hospital, Grand Rapids, MI; Diane Gollhofer, Children’s Medical Center, Dallas, TX; Megan Kelton, Seattle Children’s, Seattle, WA; Elisabeth Merkel, Stanford University Medical Center, Stanford, CA; Theresa Mottes, University of Cincinnati College of Medicine and Cincinnati Children’s Hospital, Cincinnati, OH; Mary Lee Neuberger, University of Iowa Stead Family Children’s Hospital, Iowa City, IA; Jules Rathbun, Helen DeVos Children’s Hospital, Grand Rapids, MI; Jordan M. Symons, Seattle Children’s, Seattle, WA; Brynna Van Wyk, University of Iowa Stead Family Children’s Hospital, Iowa City, IA

Author information

Authors and Affiliations

  1. Seattle Children’s, Seattle, WA, USA

    Raj Munshi

  2. University of Iowa Stead Family Children’s Hospital, Iowa City, IA, USA

    Kathy Lee-Son

  3. Helen DeVos Children’s Hospital, Grand Rapids, MI, USA

    Richard M. Hackbarth

  4. University of Texas Southwestern Medical Center, Dallas, TX, USA

    Raymond Quigley

  5. Stanford University Medical Center, Stanford, CA, USA

    Scott M. Sutherland

  6. Baxter Healthcare Corporation, Deerfield, IL, USA

    Jorge Echeverri

  7. University of Cincinnati College of Medicine and Cincinnati Children’s Hospital, Cincinnati, OH, USA

    Stuart L. Goldstein

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  1. Raj Munshi
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  2. Kathy Lee-Son
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  7. Stuart L. Goldstein
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Correspondence to Raj Munshi.

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Conflict of interest

Stuart L. Goldstein: Baxter Healthcare provided funding for the current study. Dr. Goldstein receives other grant funding, consultancy fees and is on the Expert Speaker panel for Baxter Healthcare. None of these activities were related to the current study. Scott M. Sutherland: Expert Speaker panel for Baxter Healthcare. None of these activities were related to the current study. Jorge Echeverri: Global Medical Director, Acute Therapies for Baxter Healthcare Corporation.

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Munshi, R., Lee-Son, K., Hackbarth, R.M. et al. Clinical evaluation of the Prismaflex™ HF 20 set and Prismaflex™ system 7.10 for acute continuous kidney replacement therapy (CKRT) in children. Pediatr Nephrol 35, 2345–2352 (2020). https://doi.org/10.1007/s00467-020-04664-7

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  • DOI: https://doi.org/10.1007/s00467-020-04664-7

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