Results of a US Food and Drug Administration-authorised clinical trial suggest that wearable artificial kidney could be developed as a viable, new dialysis technology that allows patients to be mobile and untethered during treatment.
The findings were reported in the journal JCI Insights. The technology may become an alternative to conventional hemodialysis for people with end-stage kidney disease.
Present-day treatment generally requires three sessions a week on a stationary machine that restricts patients' ability to walk around while it is attached and running. In contrast, a wearable device would allow patients to be mobile and untethered.
It could also provide additional treatment benefits from longer sessions or more frequent days of dialysis. The trial of a prototype for such a device was performed with seven patients at University of Washington Medical Center in Seattle.
Those leading the trial included the inventor of the device, Wearable Artificial Kidney prototype, Victor Gura of Cedar-Sinai Medical Center in Los Angeles. The trial was conducted to determine the safety and efficacy of the device - its ability to take over some functions of failed kidneys.
The researchers also wanted to ask the participants about their impressions of the experimental treatment, and to compare those with standard dialysis treatment. The patients were treated with the device for up to 24 hours.
In the patients studied, the device was shown to effectively clear the blood of waste products, like urea, creatinine, and phosphorus, while also removing excess water and salt. These are normally filtered out and removed by working kidneys.
While the usual diet for patients on standard dialysis is highly limited, their blood fluid volume of those on the wearable device remained balanced during the test, even without any diet restrictions. Regulating the volume and composition of body fluids is another job of normal kidneys.
During the trial, the participants tolerated the treatment well and did not have any serious, adverse effects. However, this trial of the device was stopped after the seventh patient because of technical problems with the device. These included the excessive formation of carbon dioxide gas bubbles in the dialysis solution and intermittent variations in solution and blood flow.
Nevertheless, the findings provide proof of concept that a wearable device along these lines could be developed as a viable, novel dialysis technology, the researchers said.