In vivo and in vitro performance of a China-made hemodialysis machine: a multi-center prospective controlled study

Abstract

Objective To evaluate the in vivo and in vitro performance of a China-made dialysis machine (SWS-4000). Methods This was a multi-center prospective controlled study consisting of both long-term in vitro evaluations and cross-over in vivo tests in 132 patients. The China-made SWS-4000 dialysis machine was compared with a German-made dialysis machine (Fresenius 4008) with regard to Kt/V values, URR values, and dialysis-related adverse reactions in patients on maintenance hemodialysis, as well as the ultrafiltration rate, the concentration of electrolytes in the proportioned dialysate, the rate of heparin injection, the flow rate of the blood pump, and the rate of malfunction. Results The Kt/V and URR values at the 1st and 4th weeks of dialysis as well as the incidence of adverse effects did not differ between the two groups in cross-over in vivo tests ( P > 0.05). There were no significant differences between the two groups in the error values of the ultrafiltration rate, the rate of heparin injection or the concentrations of electrolytes in the proportioned dialysate at different time points under different parameter settings. At weeks 2 and 24, with the flow rate of the blood pump set at 300 mL/min, the actual error of the SWS-4000 dialysis machine was significantly higher than that of the Fresenius 4008 dialysis machine ( P < 0.05), but there was no significant difference at other time points or under other settings ( P > 0.05). The malfunction rate was higher in the SWS-4000 group than in the Fresenius 4008 group ( P < 0.05). Conclusions The in vivo performance of the SWS-4000 dialysis machine is roughly comparable to that of the Fresenius 4008 dialysis machine; however, the malfunction rate of the former is higher than that of the latter in in vitro tests. The stability and long-term accuracy of the SWS-4000 dialysis machine remain to be improved.

Validation of a low-cost continuous renal replacement therapy dialysate fluid controller for experimental purposes

“…Current commercial dialysis machines can present UFnet errors as high as 25.1 ± 27.9 mL, although mean UFnet errors less than 30 mL/h are considered acceptable for some authors in the adult patient's literature [27]. Additionally, in the validation of a highprecision CRRT machine for infants and children, the maximum UFnet error allowed was 1 g/h [28].…”

An integrated model using the Taguchi method and artificial neural network to improve artificial kidney solidification parameters

“…The blood and the dialysis solution thus exchange materials through the semi-permeable membrane, taking advantage of the principle of osmosis. The metabolic wastes in the blood will diffuse to the clean dialysis solution, thereby achieving the purpose of blood purification [13]. The other needle is used to allow the purified blood to flow back to the patient’s body through the artery vessel passage.…”

“…This is one of the main causes of the solidification of the artificial kidney during the hemodialysis procedure. Clinically, common causes of the solidification of the artificial kidney include insufficient blood flow in the arteriovenous fistula, an excessively high hematocrit value, and the presence of air in the artificial kidney or blood transfusion through the duct loop [13, 14].…”