TY - JOUR
T1 - Clinical evaluation of the Prismaflex™ HF 20 set and Prismaflex™ system 7.10 for acute continuous kidney replacement therapy (CKRT) in children
AU - Munshi, Raj
AU - Lee-Son, Kathy
AU - Hackbarth, Richard M.
AU - Quigley, Raymond
AU - Sutherland, Scott M.
AU - Echeverri, Jorge
AU - Goldstein, Stuart L.
N1 - Publisher Copyright:
© 2020, IPNA.
PY - 2020/12/1
Y1 - 2020/12/1
N2 - 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. [Figure not available: see fulltext.].
AB - 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. [Figure not available: see fulltext.].
KW - Acute kidney injury
KW - CKRT
KW - HF20
KW - Kidney replacement therapy
KW - Pediatric dialysis
KW - Prismaflex
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U2 - 10.1007/s00467-020-04664-7
DO - 10.1007/s00467-020-04664-7
M3 - Article
C2 - 32607769
AN - SCOPUS:85087308042
SN - 0931-041X
VL - 35
SP - 2345
EP - 2352
JO - Pediatric Nephrology
JF - Pediatric Nephrology
IS - 12
ER -