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CA.R.PE.DI.E.M.: First Continuous Dialysis Device for Pediatric Patients

CA.R.PE.DI.E.M. First Continuous Dialysis Device for Pediatric Patients

Healthcare | May, 2021

The first-of-its-kind cardio-renal pediatric dialysis emergency machine (CA.R.PE.DI.E.M.) launched by Medtronic, is a huge medical breakthrough for the accurate treatment of pediatric acute kidney injury (AKI). The true pediatric renal replacement therapy (RRT) system has the potential to reduce the mortality rate associated with AKI in children, which is currently higher than 50% in severe cases. Abrupt loss of kidney function results in acute kidney injury, mainly characterized by a decline in glomerular filtration rate (GFR) and diminished urine output. Fluid overload and AKI are especially common in critically ill neonates and children who have undergone cardiovascular surgery. AKI has been typically associated with multiple organ dysfunction, which presents more complications for children as they grow. In the past decade, there has been a steep rise in AKI incidences in children, but there is a lack of pediatric intensive care units and an absence of preventive and therapeutic interventions for significant management of AKI. The newly developed RRT system is a great advancement for providing continuous renal replacement therapy to critically ill children weighing between 2.5-10 kg

 

How is CARPEDIEM different from RRT for adults?

Before the launch of CARPEDIEM, there was no machine designed especially for small and fragile bodies needing the RRT therapy, which created a multitude of challenges for healthcare professionals to provide optimal care to children with kidney disorders. Utilizing the new Medtronic’s RRT system, now physicians can easily clean out the blood mixed with toxic fluids and waste products accurately. In the new RRT system, the hemofilter gently removes toxic fluids from the body while reducing the risk for hypotension and cardiac stability. The new system considerably reduces the error factor and the risk for pediatric patients, enabling increased precision of neonatal CRRT treatment. The renal care solution improves outcomes, provides better access to care, and improves the quality of patients suffering from severe renal injury or disease. 

 

What makes CARPEDIEM Ideal for Pediatric Renal Replacement Therapy?

The CARPEDIEM system is designed for extracorporeal blood treatment in which the purification of the blood occurs outside the body and then the purified blood returns to the patient’s system. Optimizing advanced technological features of CRRT devices used for adults in dialysis, Medtronics was able to achieve a miniaturized medical device to meet the clinical demands of small patients. The clinical data shows an efficacy rate of 97% in pediatric patients treated with CARPEDIEM system, compared to just 48% survival rate with CRRT marketed for adults. Patients treated with the new system show a remarkable decline in body fluid overload, commonly associated with a high mortality rate in children receiving adult-based CRRT.

 

The novel blood pump technology used in the CARPEDIEM features a small rotor that allows low blood flow rates, which significantly reduces the risk of blood clots in infants. Providing 1 gram per hour of blood flow, the innovative blood pumping device helps to stabilize babies while preventing damaging fluid balance errors. The CARPEDIEM filters are ultra-small, almost half the size of those normally used in CRRT machines with large circuit volume.

 

The CARPEDIEM machine weighs around 13 kg so the compact device can be easily carried and transported. The device features six inches of a user interface, three pressure transducers, three 40-mm diameter roller pumps, and two scales. Two detectors close to the effluent line and return line can monitor blood leakage and the presence of the air in the circuit respectively. The physicians can detect the severity of the problem with the alarm light atop the machine, which indicates green, yellow, and red colors. The device also comes with a 20-ml syringe pump for heparin infusion. CARPEDIEM has three pre-assembled circuits with new polysulphone membranes, prime volume, and extracorporeal circuit. The machine is designed to automatically detect the specific dialyzer and accordingly set the highest attainable performance. 

 

The three main characteristics that determine the efficiency of the new CRRT device are optimized blood flow, hemofiltration, and net UF regulation. The blood pump rate ranges from 5 to 50 ml/min, hemofiltration rate ranges from 5 ml/min with the largest dialyzer and 2.5ml/min with the smallest dialyzer. Equipped with gravimetric control and excellent scale sensitivity, CARPEDIEM ensures accurate fluid balance. The modern CRRT system automatically adjusts pump speed according to the actual delivery of fluid and terminates when the session fluid balance error reaches 50g. Although the device is highly suitable for CRRT in pediatric patients, potential complications associated with the system include low blood pressure. Besides, potential risks associated with the functioning of the device include high pressure in the dialyzer, presence of air in the dialysis circuit, and transducer alarm. 

 

Other RRT Alternatives for Pediatric Patients

Newcastle infant dialysis and ultrafiltration system (Nidus)

The Nidus CVVH system is designed for infants weighing 800 g-8 kg. The device requires a smaller bloodline and operates at a reduced blood flow. The machine withdraws 5-12.5 ml of blood from the central venous line, passes and returns across the dialysis filter, and further transcends blood into the patient every minute. The circuit consists of two operating syringes, high flux polysulfone, heparin syringe, pumped dialysate, pressure transducer, and air detector. The circuits have been designed for usage for up to 24 hours. The touchscreen displays the exact circuit position and pressure-control pattern. The machine informs the operator by giving a warning when the access line is narrow or if the blood flow rate of the baby’s line is not coupled with the adequate flow rate that the dialysis requires. Nidus records the operating status and syringe positions every one-tenth of a second to ensure safety and efficacy. The low circuit volume eliminates the need for blood priming and its ultrafiltration control supports microlitre precision. 

 

Aquadex 

The Aquadex circuit has a 33 ml volume, ultrafiltration 500 filter set with a hematocrit (HCT) monitor. The circuit facilitates blood movement with the help of two roller pumps with negative pressure, where one brings blood from the patient to filter while another removes plasma volume. The 0.12 m2 ultrafilter is made up of polysulfone membranes. The circuit has an in-line continuous HCT sensor and software that automatically stops removing fluid when the circuit reaches the prescribed HCT limit. The device is easy to use for infants without the need for intensive respiratory or blood product support.

 

CARPEDIEM requires a relatively large extracorporeal circuit and large central venous lines than Nidus, and the machine also demand a minimal supply of blood from the baby to prevent clotting. Also, Nidus needs a single lumen whereas CARPEDIEM needs a double lumen. Aquadex shows better results for critically ill patients in need of renal support than CRRT machines with a relatively larger extracorporeal circuit. CARPEDIEM and Aquadex provide convective solute clearance whereas NIDUS provides diffusive clearance.

 

Conclusion 

Pediatric continuous renal replacement therapy is challenging due to the smaller size of patients, which may weigh even lesser than 1 kg. Therefore, optimum utilization of multifaceted resources is necessary for the safe and effective provision of RRT. Miniaturized devices, membranes, and accurate CRRT machines can provide an enhanced quality of treatment for small children who are at great risk from acute kidney injury. 

According to TechSci research report on “Global Blood Transfusion Devices Market By Product (Apheresis Systems, Infusion Devices, Blood Warmers, Venous Access Devices, Filters, And Others), By Type (Blood Safety, Blood Processing, Blood Collection, Others), By Application (Blood Disorders, Autoimmune Disorders, Cancer, Renal Disorders, Surgical Procedures, And Others), By End User (Hospital, Ambulatory Surgical Centers, Dialysis Centers, Blood Bank, Other), By Region, Forecast & Opportunities, 2025”, the global blood transfusion market is anticipated to register a CAGR of over 6% by 2025. The growth can be attributed to the rising need for surgical procedures and increasing incidences of blood related disorders.

According to another TechSci research report on “Global Kidney Function Tests Market By Disease (Acute, Chronic), By Diagnosis (Blood test, Imaging tests, Biopsy, Urine Tests), By Factors (High blood pressure, Diabetes, Acute kidney injury, Cardiovascular disease, Kidney stones, Enlarged prostate or lupus, Others), By Product Type (Kits and essay, Software, Instruments), By End-User (Hospitals and clinics, Diagnostic laboratories, Research Laboratories and Institutes Others), By Region, Competition, Forecast & Opportunities, 2025”, the global kidney function tests market is expected to register a significant CAGR by 2025. The growth can be attributed to increasing alcoholic consumption and rapid innovations made in the kidney function tests market during the forecast period. 

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