First-in-U.S. Infant Acute Dialysis Technology Introduced at Cincinnati Children’s
The first continuous renal replacement therapy (CRRT) machine designed specifically for infants weighing 2.5 to 10 kg has made its American debut at Cincinnati Children’s this fall. Stuart Goldstein, MD, FAAP, FASN, FNKF, director of the Center for Acute Care Nephrology at Cincinnati Children’s, was a clinical consultant in developing the new technology called CARPEDIEM: Cardio-Renal Pediatric Dialysis Emergency Machine.
Infants with acute kidney failure and fluid overload can benefit from CARPEDIEM’s unique features, which help prevent deleterious fluid balance errors:
- The novel blood pump technology features a smaller rotor that allows for lower blood flow and less risk of blood clots. Scales are accurate within 1 gram per hour, and the slower blood flow helps stabilize babies.
- CARPEDIEM filters are half as small as those of other CRRT machines that have larger circuit volume. Saline can be used to prime the CARPEDIEM circuit, thus avoiding blood transfusions.
“This is the first true advancement in acute dialysis technology in over 20 years,” said Goldstein, “and it is the only device specifically designed for and indicated by the FDA to support children with kidney failure under 8 kilograms in size.”
To date, pediatric nephrologists and critical care physicians in the United States have had to rely on using adult CRRT machines off-label and make adaptations for babies.
The Heart Institute purchased three machines for The Center for Acute Care Nephrology (CACN). The CACN expects to treat 10-15 patients per year across the cardiac, pediatric and neonatal ICUs. A typical treatment course is seven to 14 days. CACN is the first pediatric center in the world that collaborates with all areas of critical care, including the Heart Institute, which ultimately leads to better patient outcomes.
Evolution of CARPEDIEM
The Italian physician who designed the technology, Dr. Claudio Ronco, used CARPEDIEM on his first patient in 2014. He consulted Goldstein on care of the patient, and they co-authored a paper on the first successful human case with CARPEDIEM. Together with a team of doctors, they published “Continuous renal replacement therapy in neonates and small infants: development and first-in-human use of a miniaturised machine (CARPEDIEM)” in the Lancet 2014: 383: 1807-13.
CARPEDIEM is made in Italy, and its original manufacturer was Bellco. The technology is currently owned by Medtronic.
Goldstein worked with both manufacturers to obtain approval from the U.S. Food and Drug Administration (FDA). Based on data from 38 patients in Italy, the FDA approved use of the machine in April 2020.
“Unlike previously available devices that must be adapted for infants, the new device is designed specifically for these smaller, fragile patients to increase precision and improve patient outcomes,” Goldstein says. “We are grateful to have a chance to test and validate this technology so that it can help the children in our care.”
Physicians and nursing staff at Cincinnati Children’s have received training to use CARPEDIEM and are carefully tracking patient experiences. Four patients have been supported with the CARPEDIEM in just the first four months of implementation, and CACN is sharing its experiences with other medical centers as they begin training to use this new technology.
