An infant with kidney failure is one of the most fragile and critical patients in our care. Continuous kidney replacement therapy (CKRT) is a mainstay of dialysis treatment for these patients. Improving outcomes for the smallest of CKRT patients has long been a challenge worldwide, with no major improvements in treatment or technology in recent years—until now.

In November 2020, Cincinnati Children’s pediatric intensive care unit (ICU) became the first in the nation to use the CArdio-Renal PEdiatric DIalysis Emergency Machine (Carpediem™, Medtronic, United States), a specially designed machine for providing CKRT for infants. The machine is now being used to provide lifesaving hemodialysis for infants in our neonatal ICU.

“It’s exciting to be able to use the Carpediem™ and provide therapy to babies who need CKRT, and the machine has an excellent safety profile,” says neonatologist Cara Slagle, MD. “With this novel technology, the volume of blood outside the baby’s body is much less than with a modified adult or pediatric machine. We’re seeing a survival rate to CKRT discontinuation of about 97 percent, which is consistent with data from Italy. We’re hopeful that wider use and ongoing experience could dramatically improve outcomes for infants who need CKRT.”

The machine was designed in Italy, but Cincinnati Children’s own Stuart Goldstein, MD, FAAP, was a consultant and was instrumental in its development. In 2014, Claudio Ronco, MD, director of nephrology at St. Bortolo Hospital in Vicenza, Italy, used it for the first time. He consulted Goldstein on care of the patient, and they co-authored a paper on the first successful human case with Carpediem™ (Lancet 2014: 383: 1807-13).

Based on data from Italy, the US Food and Drug Administration (FDA) approved the device in 2020. Medtronic, the medical device company, currently owns the technology.

How Carpediem Helps

Infants in kidney failure who need dialysis have conventionally been treated with modified dialysis equipment that was originally designed and built for adults. The Carpediem™ was designed just for use in young, small patients between 5 and 20 pounds. It has a smaller rotor than other CKRT machines, which allows for lower blood flow and less risk of blood clots. The slower blood flow helps stabilize babies. Accurate ultrafiltration control via calibrated scales provides precision to detect 1-gram variances.

Carpediem™ filters are half the size as those of other CKRT machines that have larger circuit volume. Crystalloid can be used to prime the Carpediem™ circuit, avoiding blood transfusions.

Sharing Knowledge and Data to Build on Success

The body of knowledge on dialysis in infants and small children is limited mainly to single-center studies. Building on Carpediem™’s early success requires a high level of collaboration, data-sharing and multicenter communication. A multicenter, multidisciplinary quality improvement and research initiative, Improving Carpediem™ Outcomes in Neonates and Infants through Collaboration (ICONIC) based out of Cincinnati Children’s, will eventually share data and information using a real-time automated dashboard between 21 institutions.

ICONIC aims to:

• Develop a multicenter network to share best practices, treatment hurdles and quality metrics in infant CKRT using the Carpediem™ device in the US.

• Assess for predictors for Carpediem™ filter life to meet prescribed goals.

• Describe survival and renal recovery post-Carpediem™ treatment.

“The collaboration is key,” Slagle says. “The study will include input from dietitians; pharmacists; nursing leadership; nephrologists; and pediatric, cardiac and neonatal intensivists. By sharing our information and experiences using Carpediem™, we’ll gain insight into ways to improve outcomes. This device really is the first development of its kind in improving CKRT outcomes for infant and pediatric patients, and we’re committed to its success here in Cincinnati and nationwide.”