Wearable Dialysis Unit Effective in Tryout

[xtrememoosetrax]

Wearable Dialysis Unit Effective in Tryout 

By Peggy Peck, Executive Editor, MedPage Today
 
LONDON, Dec. 13 -- An investigational wearable hemodialysis device demonstrated promising safety and efficacy in a pilot study of eight patients with end-stage renal disease, researchers here reported.

But three of the eight patients who tried out dialysis on the hoof for four to eight hours had serious adverse effects involving coagulation and vascular access, said Andrew Davenport, M.D., of University College Hospital Medical School, and colleagues.

Patients using the device achieved a mean flood flow of 58.6 mL/min, with a dialysate flow of 47.1 mL/min, the investigators reported in the Dec. 15 issue of The Lancet.

The mean plasma clearance rate was 22.7 mL/min and mean plasma creatinine clearance rate was 20.7 mL/min.

The device used in the trial was developed by Xcorporeal Inc., of Los Angeles.

Patients were connected to the artificial kidney by their usual vascular access for dialysis. Heparin dose was adjusted to maintain an activated partial thromboplastin ratio of 1.5 to 2.0.

Patients were encouraged to eat and drink normally during the trial and five patients who attempted to sleep during the study were able to do so.

"All patients were pleased with treatment, and had no complaints," the investigators wrote. "They stated unanimously that they would recommend this device to other patients."

Because the device is designed to be used on a daily basis for extended periods "blood flow rates were much lower than those achieved in conventional hemodialysis, as were the clearance rates for urea and creatinine."

Two patients developed clotting problems at vascular access sites, but in both cases heparin dosing had been reduced. "Thus for the wearable artificial kidney to be successful, patients require anticoagulation," they wrote.

A third patient had a temporary disconnection caused by a dislodged fistula needle, said Dr. Davenport.

All patients in the trial had been receiving hemodialysis for an average of 17.9 years and all were receiving regular hemodialysis three times a week at the time they volunteered for the study. Five of the patients were men and the average age of patients was 52.

Four of the patients had kidney failure as the result of glomerulonephritis, three had polycystic kidney disease as the cause, and one had obstructive uropathy.

The first three patients wore the device for three hours, the fourth patient wore it for seven hours and the remaining four were treated for eight hours with the wearable dialysis unit.

Compared with baseline, mean bodyweight was significantly lower after treatment (P<0.01) and the ratio of extracellular to total body fluid was also significantly lower (P=0.0019).

In a commentary, Garabed Eknoyan, M.D., of Baylor College of Medicine in Houston, wrote that the wearable artificial kidney was "a small first step in the long road to wearable blood-cleansing devices. Lessons learned from further study should pave the way for realizing the future promise of dialysis with artificial kidneys."

Dr. Davenport agreed that more studies are needed and he concluded that in order to be truly a breakthrough the wearable dialysis unit will need to be "worn continuously, or for extended periods every day to increase flows and therefore clearance rates."

************
Dr. Davenport said he had no conflicts to declare but three of his co-authors are employees of Xcorporeal, which developed the device and funded the study. Dr. Eknoyan had no financial conflicts. 

Primary source: The Lancet
Source reference:
Davenport A, et al "A wearable hemodialysis device for patients with end-stage renal failure: a pilot study" Lancet 2007; 370: 2005-10.

Additional source: The Lancet
Source reference:
Eknoyan G, "Artificial kidneys: progress and promise" Lancet 2007; 370: 1977-78.

 

[Katonsdad]

I heard this on the News the othe day . They said it was like wearing a tool belt around their
waists . I guess everyone would look like Schnieder from One Day at a Time.


Prestigious Medical Journal Publishes Data on Xcorporeal's Wearable Artificial KidneyPublished: Dec 17, 2007 08:47 AM Modified: Dec 17, 2007 08:48 AM
Prestigious Medical Journal Publishes Data on Xcorporeal's Wearable Artificial Kidney
¶ Study in The Lancet Shows Promising Results
LOS ANGELES - Xcorporeal, Inc. (AMEX:XCR) announced today that The Lancet, a leading medical journal, has published an article on the Company's Wearable Artificial Kidney (WAK) prototype device in its Journal dated December 15, 2007. The data, from a pilot study conducted by Drs. Andrew Davenport and Victor Gura at the Royal Free and University College Hospital Medical School, London, UK, showed that the WAK's clearance rate, if sustained and used continuously, could be more effective than conventional three times weekly or daily hemodialysis treatment. This proof of concept study also provides preliminary indications on the safety features of the WAK and permitted the patient to be ambulatory during treatment.
"We believe this study demonstrates the potential the WAK has in providing an ambulatory treatment solution for the more than 1.2 million worldwide dialysis patients with End Stage Renal Failure," said Dr. Victor Gura, Xcorporeal's Chief Scientific and Medical Officer. "Unlike other treatment modalities available today, the WAK might potentially offer the hope of reducing mortality and improving the quality of life of this unfortunate population. Several larger and longer clinical studies are still needed to confirm these expectations."

The WAK is a battery-powered, wearable dialysis machine that will allow users to have their blood cleansed round the clock instead of being tethered to conventional dialysis machines, intermittently, for many hours.

An abstract of the article is available for free at: http://www.thelancet.com/journals/lancet/article/ PIIS0140673607618649/abstract. The full article is also available at www.thelancet.com with a paid subscription.

[Bill Peckham]

This LA Times story includes pictures of the device.
http://www.latimes.com/features/health/la-he-lab12nov12,1,6584708.story?ctrack=4&cset=true