This application addresses broad Challenge Area (04) Clinical Research and specific Challenge Topic, 04-HD- 102: Development of Pediatric Medical Devices. The title of this project is """"""""Kidney Injury and Dysfunction Support (KIDS) - Development of a safe, accurate, and developmentally appropriate continuous renal replacement therapy (CRRT) device for the pediatric population."""""""" The economics driving the medical device industry hampers the development of pediatric devices compared to adult devices. Consequently clinicians """"""""adapt"""""""" many adult devices for pediatric patients due to a lack of appropriate alternatives. As a result, these adult devices are used for pediatric conditions without proper design, safety, and effectiveness having been demonstrated. Pediatric physicians are reliant on anecdotes rather than scientific data, regarding which adaptations are safe and efficacious. Use of these life-saving adapted adult CRRT devices in children is plagued with safety and quality concerns such as inaccurate fluid balance leading to hypotension, excessive extracorporeal blood volumes leading to increased blood transfusion needs, and lack of compatibility with other extracorporeal devices such as extracorporeal membrane oxygenation. For this Challenge Grant, we have assembled a multi-disciplinary team of pediatricians and bioengineers, and describe the prototype development and testing of a pediatric specific CRRT device. The long term objective of this project is to provide a safe and accurate method of CRRT for the diverse size, age, and developmental ranges seen in the pediatric population. Design requirements include: 1) preservation of patient's safety, 2) accuracy in fluid balance, 3) easy integration with other extracorporeal systems, 4) maintenance of sterility, 5) ease of operation, and 6) compact size. Particular effort will be taken in optimizing the design to eliminate the need for blood priming, reduction of the extracorporeal volume to an appropriate size (<15% of a patient's calculated blood volume), while maintaining acceptable hemolysis and thrombosis risks. After fabrication, we will provide validation and comparison of the KIDS CRRT prototype device to the predicate adult CRRT devices. In addition, the ECMO/KIDS CRRT implementation will be compared to a commonly used method of providing CRRT using standard IV pumps and a urimeter. Metrics for comparison will be: fluid balance accuracy, inflammatory markers, complement activation, markers of hemolysis, white blood cell activation, and platelet count.
This project addresses the management of acute kidney injury, a life-threatening condition seen commonly in the pediatric intensive care unit. There is no device approved by the Food and Drug Administration to treat critically ill, unstable children who have kidney failure. This project addresses that need by creating and testing a pediatric specific device to provide kidney support for critically ill children.
| Santhanakrishnan, Arvind; Nestle, Trent T; Moore, Brian L et al. (2013) Development of an accurate fluid management system for a pediatric continuous renal replacement therapy device. ASAIO J 59:294-301 |
| Santhanakrishnan, Arvind; Nestle, Trent; Moore, Brian L et al. (2013) Design and validation of a diaphragm pump for pediatric CRRT during ECMO. Int J Artif Organs 36:892-9 |
| Paden, Matthew L; Warshaw, Barry L; Heard, Micheal L et al. (2011) Recovery of renal function and survival after continuous renal replacement therapy during extracorporeal membrane oxygenation. Pediatr Crit Care Med 12:153-8 |
