By Laura Serrano / July 29, 2022
Fluid balance is a critical issue in numerous pediatric care settings, yet there is still a clear gap in what the industry offers – from limited product innovations to the type and amount of research. Nuwellis has been active in the pediatric care community this spring, presenting at major conferences and speaking with pediatric physicians and providers at events across the country about pediatric fluid management and the needs of their patients. We’re also hard at work developing a new pediatric ultrafiltration product that meets the specific needs of children and babies with limited kidney function.
In April, Nuwellis was in Denver for the annual Pediatric Academic Societies (PAS) meeting, where the use of Aquadex for pediatric patients was the focus of three abstracts. Together, these papers are adding data to the growing body of research supporting the negative impact of fluid overload and the positive potential of ultrafiltration for children and babies.
Nuwellis was also proud to support the Children’s Minnesota StarGala in April, benefitting the health system’s neonatal program. Community building starts at home, and we’re honored to partner with the children’s health system in our own backyard here in the Twin Cities to support parents and newborns in Minnesota.
A few weeks later in early May, Nuwellis traveled to Atlanta for the PC4 hybrid Spring Conference sponsored by Children’s Atlanta. PC4 stands for Pediatric Cardiac Critical Care Consortium, and the event was focused on the future of cardiac care for children. At PC4 we discussed Aquadex and the current needs in pediatric fluid management with over 100 healthcare professionals in the field.
Children with pediatric kidney disease go through a lot already. They need the fluid removal process to be as gentle and precise as possible. For critically ill pediatric patients, managing fluid balance is crucial in reducing the risk of morbidity and mortality. Aquadex SmartFlow allows for gentler, more precise fluid removal that is adjustable to the patient.
A customizable rate of fluid removal means Aquadex can achieve the needed fluid balance in pediatric patients with less extracorporeal volume (ECV), or blood outside the body. Minimizing ECV is crucial for children especially, because they’re so much smaller than adult patients, with far less blood to spare. Aquadex is cleared by the FDA for use in adults and pediatric patients weighing 20 kg (44 lbs.) or more.
“Ultrafiltration using the Aquadex system provides an easy to use, safe and effective therapy for managing fluid balance in pediatric patients,” said David Askenazi, MD, MSPH and director of the Pediatric and Infant Center for Acute Nephrology (PICAN) at Children’s of Alabama and University of Alabama at Birmingham. “I’m grateful for the commitment from the company and I’m proud to partner with Nuwellis to provide meaningful data that helps the medical community determine when and how to implement Aquadex for those who suffer from pediatric kidney disease.”
Today, critically-ill children and babies with kidney failure are lacking in options for their care. Too often, clinicians have to adapt treatments designed for adults to small children with different needs and risks. Unfortunately, diuretics and adult continuous renal replacement therapy (CRRT) devices can be poorly tolerated by pediatric patients.[1][2][3][4]
Nuwellis is working with leading pediatric nephrologists to fill this unmet need and create a pediatric-specific CRRT device— one with a smaller extracorporeal volume (ECV) than existing devices. Ultrafiltration therapy with a device containing small ECV may be better tolerated than CRRT machines with larger ECV in relation to patient blood volume. This is critical for pediatric patients.
Building on Aquadex, Nuwellis is developing a fully integrated pediatric CRRT device designed to provide care for small babies and children. CRRT machines are fluid management devices designed to aid or replace kidney function by removing excess fluid and toxins when the patient’s kidneys are unable to support the demands of the body. Aided by a $1.7 million grant from the National Institutes of Health (NIH), Nuwellis is working with Koronis Biomedical Technologies Corporation (KBT), the grant recipient, to design and develop a custom pediatric product that will enable doctors to give better, more kid-friendly care to children and babies with limited kidney function.
Newborns without sufficient kidney function need life-sustaining therapies until they are big enough for chronic dialysis machines. In these situations, fluid balance is critical, and so is preserving blood during the process. Physicians today are expressing the need for better neonatal fluid management therapies that support the small size of children with minimal blood in the device circuit. Nuwellis, KBT, and our clinical partners are working to make it a reality for doctors, pediatric patients, and their families.
You can learn more about our approach to pediatric kidney care here
Sources:
[1] Wang S, et al. Perfusion., vol. 27, no. 5, pp. 438-46, Sep 2012.
[2] Askenazi D, et al. Pediatr Nephrol., vol. 31, no. 5, pp. 853-860, May 2016.
[3] Chakravarti S, et al. Pediatr Rep., vol. 8, no. 2, p. 6596, 23 Jun 2016.
[4] Raina R, et al. PLoS ONE, vol. 12, no. 5, p. e0178233, 30 May 2017.
