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Clinical validation of miniature wearable dialysis machine

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Improved dialysis technology could facilitate home treatment

A new medical device developed with support from the EU could facilitate home dialysis, saving millions from the need to attend dialysis machines in hospital. The development may considerably improve patients’ quality of life and bring down healthcare costs.

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In 2018, approximately 3.4 million patients with end- stage kidney disease received dialysis treatment, administered either as haemodialysis (HD) (89 %) or peritoneal dialysis (PD) (11 %). Although lifesaving, dialysis does have major shortcomings. The treatment is time-consuming, and removal of waste molecules and excess water is inadequate, contributing significantly to poor life quality, severe health problems and high mortality (around 15 % per year). Healthcare costs for dialysis are very high, representing a financial burden of approximately EUR 300 billion annually for Europe. This cost, because of an ageing population and the prevalence of obesity and diabetes, can only climb higher. Karin Gerritsen, principal investigator on the WEAKID project hosted at the University Medical Centre Utrecht (UMCU), explains: “PD has some advantages compared to HD. It provides continuous and gradual dialysis, resulting in stable toxin concentrations. This is in contrast to the peaks and troughs (sawtooth) pattern observed in HD.” PD, which is performed at home, also has the benefit of permitting more autonomy as the patient is able to move, staying active socially and economically. However, current PD technology has some major drawbacks that make the technique less popular. The level of blood purification is low, preparation of the equipment is time-consuming, there is a high incidence of recurrent infection of the peritoneal membrane, and the membrane can be damaged by the process. On average, patients have to switch over to HD after around 3.7 years. WEAKID’s innovation is the development of a new PD system. Instead of a stagnant filling as in traditional PD, WEAKID continuously circulates and regenerates dialysate in the abdominal cavity, resulting in a significant improvement in blood purification. “By improving the efficiency of the procedure, we can reduce the number of exchanges (drain and refill of the abdominal cavity) down to once a day versus 4-6 times a day needed by the current process,” explains Gerritsen. Since the exchange procedure is less frequent, WEAKID may also lower the rates of peritonitis. “Our system reduces the number of external (dis)connections of the PD catheter, which is where the risk of contamination comes in,” Gerritsen adds. The WEAKID system consists of a replaceable cartridge with dialysate and sorbents. The system exchanges dialysis fluid via a standard, abdominal catheter. The fluid is cleansed in the device by a sorbent unit. The dialysate provides additional removal of waste solutes. The system slowly releases the glucose needed for osmotic removal of excess fluid. Very high glucose concentrations, as used in traditional PD and which are harmful to the peritoneal membrane, are no longer required. This helps to preserve the membrane function. “Since WEAKID eliminates important drawbacks of peritoneal dialysis, our system is expected to cause a shift from (in-centre) haemodialysis to peritoneal dialysis at home, helping people to remain autonomous and reducing costs to healthcare systems by between EUR 15 000 and 40 000 per patient a year, compared to in-centre haemodialysis,” Gerritsen says.

Keywords

WEAKID, dialysis, kidney disease, home dialysis, haemodialysis, peritoneal dialysis, patient, autonomy, quality of life, healthcare costs

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