Design, Development, and Validation of KIDS-CRRT - a Safe and Accurate Pediatric Continuous Renal Replacement Device

摘要

Nearly 3,600 critically ill children per year with acute kidney injury receive life-saving continuous renal replacement therapy (CRRT) in the United States. However, there is no CRRT device approved by the Food and Drug Administration for use in pediatric patients. Thus, clinicians unsafely adapt adult CRRT devices for use in the pediatric patients due to lack of safer alternatives. These adult adapted CRRT devices operate with large extracorporeal blood volume relative to patient weight. Additionally, the adult CRRT devices provide inaccurate fluid balance with error in the range of 5-12% (based on expected output) between ultrafiltrate (UF) removal and replacement fluid (RF) infusion rates, leading to clinical complications. An unmet clinical need exists for a low extracorporeal volume, safe, accurate pediatric Kidney Injury and Dysfunction Support (KIDS)-CRRT device.