Promising results for pilot trial of wearable hemodialysis device

December 13, 2007

A pilot trial of a wearable haemodialysis device* to improve the quality of life for patients with kidney failure has delivered promising results. These are the conclusions of authors of an Article in this week's edition of The Lancet.

Nearly 1300000 patients worldwide have chronic kidney failure that requires treatment with either dialysis or renal transplantation. Haemodialysis is an established treatment for such patients, yet their survival remains poor due to increased cardiovascular risk, and is similar to that of patients with solid organ cancers. The quality of life and survival of haemodialysis patients could be improved by increasing both the dose of dialysis (in terms of clearance of urea/toxins from the body) and the frequency of dialysis â€" from three times a week to five times a week or even daily, since the latter is closer to physiological norms. The idea of a wearable haemodialysis device - so that patients could perform their own treatment at home â€" was first postulated in the 1970s, with a "wearable kidney" developed at that time. However, recent technological advances have meant that the system could be miniaturised.

Dr Andrew Davenport, University College London (UCL) Centre for Nephrology, Royal Free and University College Medical School, London, UK, and colleagues studied five men and three women with end-stage kidney failure, average age just under 52 years, who were established on regular haemodialysis and were fitted with the wearable haemodialysis device for between four and eight hours.

The researchers found there were no important cardiovascular changes and no adverse changes in serum electrolytes or the acid-base balance in the patients' blood. Rates of blood flow, dialysate flow and urea and creatine clearance were all satisfactory, although they were all significantly lower than in conventional dialysis (for example a blood flow of 59ml per min compared with 300ml UK average in conventional dialysis). However, once the device can be worn for long, continuous periods, the differing flow rate will be become less of an issue because a long period at a low flow rate can clear as much or more toxins from the blood as the shorter period with a higher flow rate experienced three times per week in conventional dialysis. Although the study objective was not to return a patient to their post-dialysis target weight, fluid was successfully removed during treatment, with no adverse cardiovascular changes and despite patients being encouraged to eat and drink during treatment. All patients were pleased with the treatment, and had no complaints. Even those who wished to sleep while wearing the device were able to without difficulty. The patients stated unanimously that they would recommend the device to other patients.

The authors conclude by calling for larger trials of the device to confirm safety and efficacy of the treatment. They say: "The device has the potential to become a practical means of delivering extended and more frequent dialysis to patients with end-stage kidney failure."

In an accompanying Comment, Dr Garabed Eknoyan, Baylor College of Medicine, Houston, Texas. USA, says: "The wearable artificial kidney reported today is a small first step in the long road to wearable blood-cleansing devices. Lessons learned from further study should pave the way for realising the future promise of dialysis with artificial kidneys."
-end-
The paper associated with this release is at http://multimedia.thelancet.com/pdf/press/Haemodialysis.pdf

*Notes to editors: A jpeg of a patient wearing the device is attached to this press mailing; you are free to use this in your publication.

Dr Andrew Davenport, University College London (UCL) Centre for Nephrology, Royal Free and University College Medical School, London, UK T) 0207-794-0500 extn 34773 E) Dr Andrew Davenport

Dr Garabed Eknoyan, Baylor College of Medicine, Houston, Texas. USA T) +1 713 798 4748 E) geknoyan@bcm.edu

Lancet

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