1. Clinical evaluation of the Prismaflex™ HF 20 set and Prismaflex™ system 7.10 for acute continuous kidney replacement therapy (CKRT) in children.
- Author
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Munshi, Raj, Lee-Son, Kathy, Hackbarth, Richard M., Quigley, Raymond, Sutherland, Scott M., Echeverri, Jorge, and Goldstein, Stuart L.
- Subjects
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ACUTE kidney failure , *CONFIDENCE intervals , *HEMODIALYSIS , *HEMODIALYSIS equipment , *LONGITUDINAL method , *MEDICAL cooperation , *RESEARCH , *DESCRIPTIVE statistics , *BLOOD urea nitrogen , *HEMODIAFILTRATION - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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