About 3,600 children a year in the United States need renal replacement therapy and acute kidney injury is common in critically ill children affecting about 5% of 480,000 PICU admissions or 24,000 children. There is currently no device that is approved by the FDA to provide Continuous Renal Replacement Therapy in pediatric patients, and thus adult devices are adapted for this use. However, adult CRRT devices are not designed to be used in the pediatric population. Problems include large extracorporeal volume, alarm/flow settings, integration with other extracorporeal devices, and inaccuracies noted in fluid balance. Clinicians and hospitals are faced with the dilemma of providing therapy with the adult device against the FDA’s and the manufacturer’s recommendation or following the FDA's recommendations and risking inadequate treatment of kidney failure.
KIDS CRRT is a safe, accurate, low extracorporeal volume CRRT device developed specifically for the pediatric population. KIDS CRRT uses a “conservation of volume” approach to ensure accuracy.
This project was funded by the Atlanta Pediatric Device Consortium and the consortium also identified several additional sources of funding. When the project joined the consortium the device was in the prototyping stage of development.