Masoud Beizai

A wearable haemodialysis device for patients with end-stage renal failure: a pilot study

BACKGROUND More frequent haemodialysis can improve both survival and quality of life of patients with chronic kidney disease. However, there is little capacity in the UK to allow patients to have more frequent haemodialysis treatments in hospital and satellite haemodialysis units. New means of delivering haemodialysis are therefore required. Our aim was to assess the safety and efficiency of a wearable haemodialysis device. METHODS Eight patients with end-stage kidney failure (five men, three women, mean age 51.7 [SD 13.8] years) who were established on regular haemodialysis were fitted with a wearable haemodialysis device for 4-8 h. Patients were given unfractionated heparin for anticoagulation, as they would be for standard haemodialysis. FINDINGS There were no important cardiovascular changes and no adverse changes in serum electrolytes or acid-base balance. There was no evidence of clinically significant haemolysis in any patient. Mean blood flow was 58.6 (SD 11.7) mL/min, with a dialysate flow of 47.1 (7.8) mL/min. The mean plasma urea clearance rate was 22.7 (5.2) mL/min and the mean plasma creatinine clearance rate was 20.7 (4.8) mL/min. Clotting of the vascular access occurred in two patients when the dose of heparin was decreased and the partial thromboplastin time returned towards the normal reference range in both of these patients. The fistula needle became dislodged in one patient, but safety mechanisms prevented blood loss, the needle was replaced, and treatment continued. INTERPRETATION This wearable haemodialysis device shows promising safety and efficacy results, although further studies will be necessary to confirm these results.

β2-Microglobulin and Phosphate Clearances Using a Wearable Artificial Kidney: A Pilot Study

BACKGROUND Additional small-solute clearances during standard thrice-weekly hemodialysis treatments have not improved patient survival. However, these treatments have limited middle-molecule clearances. Thus, newer therapies designed to increase middle-molecule clearances need to be developed and evaluated. STUDY DESIGN Pilot clinical trial to measure beta(2)-microglobulin and phosphate clearances with a wearable hemodialysis device. SETTING & PARTICIPANTS 8 regular hemodialysis patients under the care of a university teaching hospital. INTERVENTION Patients were fitted with a wearable hemodialysis device for 4 to 8 hours. OUTCOMES All patients tolerated the treatment. RESULTS Average amount of beta(2)-microglobulin removed was 99.8 +/- 63.1 mg, with mean clearance of 11.3 +/- 2.3 mL/min, and an average of 445.2 +/- 326 mg of phosphate was removed, with mean plasma phosphate clearance of 21.7 +/- 4.5 mL/min. These clearances compared favorably with mean urea and creatinine plasma clearances (21.8 +/- 1.6 and 20.0 +/- 0.8 mL/min, respectively). LIMITATIONS Proof-of-concept preliminary trial. Additional studies are warranted to confirm these positive preliminary data. CONCLUSIONS This wearable artificial kidney potentially provides effective beta(2)-microglobulin and phosphate clearances and, by analogy, middle-molecule clearances.

Continuous renal replacement therapy for congestive heart failure: the wearable continuous ultrafiltration system.

Ultrafiltration is effective in the treatment of fluid and sodium overload in congestive heart failure. There is no available device to provide this therapy to ambulatory patients. We built and tested in vivo a wearable belt that can provide continuous ultrafiltration, 168 hours a week. Nine pigs underwent ureteral ligation and subsequently were allowed fluids ad lib, producing fluid overload. Next day, ultrafiltration was performed for 8 hours. The device consists of a hollow-fiber filter, a 9 V battery-operated pulsatile blood pump, a micro pump for heparin infusion, and another micro pump to control ultrafiltration rate. Blood flow was 65 ml/min and the weight of the device is less than 2.5 lb. Fluid removal rate ranged from 0 to 700 ml/h and averaged 106 ml/h. Salt removed was 7.6 g. No complications were observed. The potential impact on the quality of life of these patients by reducing the shortness of breath, leg swelling, and returning their ability to enjoy salt in their food might be significant, and a reduction in morbidity could be expected. The economic impact in reducing hospital admissions and length of stay, intensive care unit utilization, and drug consumption could be significant. Further studies are needed to compare this innovative approach with traditional drug-based therapy.

An experimental and numerical study of the flow and mass transfer in a model of the wearable artificial kidney dialyzer

BackgroundPublished studies of the past decades have established that mass transfer across the dialyzer membrane is governed by diffusion, convection and osmosis. While the former is independent of the pressure in the liquids, the latter two are pressure dependent and are enhanced when the pressure difference across the membrane is increased. The goal of the present study is to examine the impact of pulsatile flow on the transport phenomena across the membrane of a high-flux dialyzer in a wearable artificial kidney (WAK) with a novel single small battery-operated pulsatile pump that drives both the blood and dialysate in a counter-phased manner, maximizing the trans-membrane pressure.MethodsBoth in-vitro experimental and numerical tools are employed to compare the performance of the pulsatile WAK dialyzer with a traditional design of a single-channel roller blood pump together with a centrifugal pump that drives the dialysate flow. The numerical methods utilize the axisymmetric Navier-Stokes and mass transfer equations to model the flow in the fibers of the dialyzer.ResultsWhile diffusion is still the dominating transport regime, the WAK pump enhances substantially the trans-membrane pressure and thus increases mass convection that might be as high as 30% of the overall transfer. This increase is obtained due to the design of the pulsatile WAK pump that increases ultrafiltration by increasing the trans-membrane pressure.ConclusionsThe experimental and numerical results revealed that when pumping at similar flow rates, a small battery-operated pulsatile pump provides clearances of urea and creatinine similar as or better than a large heavy AC-powered roller pump.

Experimental and computational studies of negative near-wall shear stress in the human aorta and its correlation with various stages of CHF

In this article, we report our in vitro observations demonstrating that reduced blood flow combined with increased heartbeat can lead to a retrograde flow adjacent to the vessel wall and thereby high negative wall shear stress over a major part of cardiac cycle. We attempt to map the correlation between the level of retrograde flow in the descending aorta and the severity of congestive heart failure (CHF), using both experimental methods and computational fluid dynamics (CFD) simulations.