Acute kidney injury is common in critically ill children and renal replacement therapies provide a life saving therapy to a subset of these children. However, there is no Food and Drug Administration approved device to provide pediatric continuous renal replacement therapy (CRRT). Consequently, clinicians adapt approved adult CRRT devices for use in children due to lack of safer alternatives. Complications occur using adult CRRT devices in children due to inaccurate fluid balance (FB) between the volumes of ultrafiltrate (UF) removed and replacement fluid (RF) delivered. We demonstrate the design and validation of a pediatric fluid management system for obtaining accurate instantaneous and cumulative FB. Fluid transport was achieved via multiple novel pulsatile diaphragm pumps. The conservation of volume principle leveraging the physical property of fluid incompressibility along with mechanical coupling via a crankshaft was used for FB. Accuracy testing was conducted in vitro for 8-hour long continuous operation of the coupled UF and RF pumps. The mean cumulative FB error was <1% across filtration flows from 300 mL/hour to 3000 mL/hour. This approach of FB control in a pediatric specific CRRT device would represent a significant accuracy improvement over currently used clinical implementations.

A novel diaphragm pump concept has been presented for providing CRRT during ECMO in the pediatric population. Improvement of the pump accuracy compared to currently used CRRT pumps was demonstrated via in vitro testing.

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.

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