ArticlesContinuous renal replacement therapy in neonates and small infants: development and first-in-human use of a miniaturised machine (CARPEDIEM)
Introduction
The increase in incidence of acute kidney injury and its association with poor outcomes in the general population1 have led to a call for action2 to improve early diagnosis, institute new preventive measures, and develop new treatments to improve clinical outcomes.2 Acute kidney injury in adult patients, and to a lesser extent in children, has received a great deal of attention, with the development of standard classification systems,3, 4, 5, 6, 7 assessment of novel biomarkers,8, 9 and recognition of the association between acute kidney injury and the development of chronic kidney disease.10, 11, 12 However, such progress has not been made for infants and neonates.13
Acute kidney injury has been described as a rare disorder in neonates, occurring in 1–2% of the hospital-admitted neonatal population.14 However, more recent single-centre systematic investigation15 into neonatal acute kidney injury using modern definitions showed that it occurs in 16% of newborn infants weighing more than 2 kg who are admitted to neonatal intensive care. Previous underappreciation of the prevalence of the disorder has made neonatal acute kidney injury an orphan-like disease, and has held back the development of technology specifically for renal replacement therapy in infants.
Existing technology for renal replacement therapy is designed for use in adults and has been inadequately adapted for use in neonates and infants, providing challenges to safe and effective treatment. Because of the unique nature of acute kidney injury in infants and its severe complications, a dedicated technology capable of managing blood purification and fluid balance in very small children is sorely needed. Therefore, we undertook a project to develop a continuous renal replacement therapy (CRRT) machine designed specifically for patients of less than 10 kg bodyweight (CARPEDIEM; Cardio-Renal Pediatric Dialysis Emergency Machine), particularly neonates and premature infants. Here we describe the development of the project and report the first use of the CARPEDIEM for the treatment of a newborn baby with clinical indications for CRRT.
Section snippets
Development
We prospectively planned a 5-year project to conceive, design, and create a new miniaturised CRRT machine for neonates and small infants. First, we assessed the limitations and problems with existing CRRT technology and identified the technical and clinical requirements for a new device. The goal was to create a machine with reduced priming volumes and the capacity to accurately handle very low blood and ultrafiltration flows. In small children, total blood volume ranges 200 to 800 mL, and
Results
After 30 months in development, the CARPDIEM was approved for human use. The machine features miniaturised components and fluid control capability suitable for newborn babies and small infants within a weight range of 2·5–10·0 kg (appendix).2, 16 It can operate at a unique range of low flows and pressures, with an accuracy of fluid balance of about 1 g. All of these specifications have been thoroughly validated in several sessions of in-vitro laboratory tests done by four independent operators.
Discussion
CARPEDIEM, a CRRT platform designed specifically for neonates and small infants, was successfully used to manage a critically ill neonate of 2·9 kg bodyweight with multiple organ failure and severe fluid overload (panel). In the past, CRRT machines designed for adults were adapted for paediatric use by simply modifying the operational parameters via software and by using extracorporeal circuits with lower priming volumes. However, these modifications were adequate only for paediatric patients
References (25)
- et al.
Congenital heart surgery in infants: effects of acute kidney injury on outcomes
J Thorac Cardiovasc Surg
(2012) - et al.
Modified RIFLE criteria in critically ill children with acute kidney injury
Kidney Int
(2007) - et al.
The severity of acute kidney injury predicts progression to chronic kidney disease
Kidney Int
(2011) - et al.
3–5 year longitudinal follow-up of pediatric patients after acute renal failure
Kidney Int
(2006) - et al.
Pediatric patients with multi-organ dysfunction syndrome receiving continuous renal replacement therapy
Kidney Int
(2005) - et al.
Acute hemodialysis of infants weighing less than five kilograms
Kidney Int
(1994) - et al.
Elimination of proinflammatory cytokines in pediatric cardiac surgery: analysis of ultrafiltration method and filter type
J Thorac Cardiovasc Surg
(2004) - et al.
Do peritoneal catheters remove pro-inflammatory cytokines after cardiopulmonary bypass in neonates?
Ann Thorac Surg
(2000) - et al.
Fluid overload and mortality in children receiving continuous renal replacement therapy: the prospective pediatric continuous renal replacement therapy registry
Am J Kidney Dis
(2010) - et al.
The epidemiology of severe acute kidney injury: from BEST to PICARD, in acute kidney injury: new concepts
Nephron Clin Pract
(2008)
American Society of Nephrology Renal Research Report
J Am Soc Nephrol
Acute renal failure—definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group
Crit Care
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