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

BioMedical Engineering OnLine

Wen-Ge Li¹  Xiang-Mei Chen²  Guang-Yan Cai²  Xue-Feng Sun²  Yong Wang²  Dong Zhang²  Hui-Min Luo³  Ai-Hua Zhang⁴  Ming Shi⁵  Rong Wang⁶  Li-Rong Hao⁷  Hong-Li Jiang⁸ 

[1] Department of Nephrology, China-Japan Friendship Hospital;Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of Nephrology, State Key Laboratory of Nephrology, National Clinical Research Center for Chronic Kidney Diseases;Department of Nephrology, First People’s Hospital of Yunnan Province;Department of Nephrology, Peking University Third Hospital;Department of Nephrology, Renmin Hospital of Wuhan University;Department of Nephrology, Shandong Provincial Hospital;Department of Nephrology, the First Affiliated Hospital of Harbin Medical University;Department of Nephrology, the First Affiliated Hospital of Xi’an Medical University;

关键词: Hemodialysis machine;    Performance;    Safety;    China-made;   

DOI  :  10.1186/s12938-017-0387-y

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown