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

Autor:	Stuart L. Goldstein, Jorge Echeverri, Scott M. Sutherland, Kathy Lee-Son, Raymond Quigley, Raj Munshi, Richard Hackbarth
Rok vydání:	2020
Předmět:	Male Nephrology medicine.medical_specialty Pediatrics Continuous Renal Replacement Therapy 030232 urology & nephrology Blood volume 030204 cardiovascular system & hematology Extracorporeal Blood Urea Nitrogen 03 medical and health sciences 0302 clinical medicine Kidney Replacement Therapy Internal medicine medicine Humans Prospective Studies Child Adverse effect Blood urea nitrogen business.industry Acute kidney injury Acute Kidney Injury medicine.disease Child Preschool Creatinine Pediatrics Perinatology and Child Health Female business Clinical evaluation
Zdroj:	Pediatric Nephrology. 35:2345-2352
ISSN:	1432-198X 0931-041X
DOI:	10.1007/s00467-020-04664-7
Popis:	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.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.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.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.
Databáze:	OpenAIRE
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