Miniaturized Dialysis Device Treats Neonate Organ Dysfunction

A miniaturized continuous renal replacement therapy (CRRT) machine provides multiple organ support in babies and small infants.

Developed by researchers at San Bortolo Hospital (Vicenza, Italy), the miniaturized Cardio-Renal Pediatric Dialysis Emergency Machine (CARPEDIEM) device was created specifically for neonates and small infants, since off-label units are not designed for infants smaller than 15 kg, and need to be modified for use. The main characteristics of the CARPEDIEM are a low priming volume of the circuit (at less than 30 mL), miniaturized roller pumps, and accurate ultrafiltration control via calibrated scales, with a precision of one gram.

Following in vitro laboratory tests, meeting European regulatory requirements, and receiving a license for human use, the researchers treated a 2.9 kg neonate with hemorrhagic shock, multiple organ dysfunction, and severe fluid overload for more than 400 hours with the CARPEDIEM, using continuous venovenous hemofiltration, single-pass albumin dialysis, blood exchange, and plasma exchange. The patient's 65% fluid overload, raised creatinine and bilirubin concentrations, and severe acidosis were all managed safely and effectively.

As a result, and despite the severity of the illness, organ function was eventually restored and the baby girl survived and was discharged from hospital with only mild renal insufficiency that did not require renal replacement therapy. Since then, about 10 other babies have been treated with the machine across Europe. The study describing the CARPEDIEM and the treatment provided was published online on May 24, 2014, in the Lancet.

“The CARPEDIEM could reduce the range of indications for peritoneal dialysis, widen the range of indications for CRRT, make the use of CRRT less traumatic, and expand its use as supportive therapy even when complete renal replacement therapy is not indicated,” concluded lead author Claudio Ronco, MD, of the department of nephrology, dialysis, and transplantation, and colleagues. Dr. Ronco is also the director of the International Renal Research Institute (IRRIV) at San Bortolo Hospital and recipient of numerous international awards.

“This is a pretty major advance for the smallest infants. I can't imagine the baby would have survived with the current technology,” wrote associate professor of pediatrics Bethany Foster, MD, of the Montreal Children's Hospital (Canada), in an accompanying commentary. She added, “Doctors should be cautious in deciding which babies to treat. You have to be especially vigilant with very small babies because what you're often doing amounts to heroic treatment. We need to be careful that we don't just do things because we can.”

Related Links:
San Bortolo Hospital
Montreal Children's Hospital