Characterization of a Low Extracorporeal Volume, High Accuracy Pediatric Continuous Renal Replacement Therapy Device

Abstract

The incidence of acute kidney injury (AKI) is commonly seen in critically ill children, the origins of which may be traced to a wide range of conditions such as inborn errors of metabolism, sepsis, congenital heart defects, bone marrow and organ transplantation, and to a lesser extent from multiple organ dysfunction syndrome (MODS) [1]. It is vital to provide a form of fluid and electrolyte clearance in these patients until native renal function improves. 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. Complications observed with using adult adapted CRRT devices in children include hypotension, hemorrhage, thrombosis, temperature instability, inaccurate fluid balance between ultrafiltrate (UF) removed from and replacement fluid (RF) delivered to the patient, electrolyte disorders, and alteration of drug clearance. This research addresses this unmet clinical need through the design, mechanical and biological characterization of a pediatric specific Kidney Injury and Dysfunction Support (KIDS) CRRT device that provides high accuracy in fluid balance, reduces extracorporeal blood volume, and eliminates other problems associated with using adapted adult CRRT devices in children.