Objective To explore the method of safety and efficacy validation of hemodialysis machine,and observe the clinical efficacy of OBERS-3000 multifunctional hemodialysis machine.Methods Randomized,open,two-phase crossove...Objective To explore the method of safety and efficacy validation of hemodialysis machine,and observe the clinical efficacy of OBERS-3000 multifunctional hemodialysis machine.Methods Randomized,open,two-phase crossover and positive control design,a total of 72 patients from two hospitals were included.OBERS-3000 multifunctional hemodialysis machine was the test machine,and the Fresenius 4008 series hemodialysis machine was as the control machine,indicators of blood routine test,serum electrolytes,liver and kidney function test,blood gas analysis,CRP were compared,body weight before and after hemodialysis,ultrafiltration volume were recorded,urea clearance index,urea reduction ratio were calculated.The XL90 conductivity meter was connected in series in the test machine,to monitor the temperature,conductance,venous pressure and arterial pressure during the dialysis in real time,and the measured value were compared with the machine monitoring value.Results Both of the test machine and the control machine could effectively eliminate creatinine,urea nitrogen and other uremic toxins,could continuously supply qualified dialysate,and precisely control the ultrafiltration volume.There were no significant differences in temperature,conductance,venous pressure and arterial pressure monitoring with the real time measured value by XL90 conductivity meter.Conclusions OBERS-3000 multifunctional hemodialysis machine can effectively eliminate uremic toxins,maintain electrolyte and acid-base balance,and can accurately display the monitoring parameters.展开更多
基金Guangdong Obers Blood Purification Academician Work station(2013B090400004)Guangdong University blood purification technology and Engineering Research Center(GCZX-A1104)+2 种基金Guangzhou entrepreneurial leader talent/LCY201215Guangdong science and technology project in the field of social de velopment(2013B021400002)Guangdong Provincial Center for clini cal engineering of blood purification(507204531040)
文摘Objective To explore the method of safety and efficacy validation of hemodialysis machine,and observe the clinical efficacy of OBERS-3000 multifunctional hemodialysis machine.Methods Randomized,open,two-phase crossover and positive control design,a total of 72 patients from two hospitals were included.OBERS-3000 multifunctional hemodialysis machine was the test machine,and the Fresenius 4008 series hemodialysis machine was as the control machine,indicators of blood routine test,serum electrolytes,liver and kidney function test,blood gas analysis,CRP were compared,body weight before and after hemodialysis,ultrafiltration volume were recorded,urea clearance index,urea reduction ratio were calculated.The XL90 conductivity meter was connected in series in the test machine,to monitor the temperature,conductance,venous pressure and arterial pressure during the dialysis in real time,and the measured value were compared with the machine monitoring value.Results Both of the test machine and the control machine could effectively eliminate creatinine,urea nitrogen and other uremic toxins,could continuously supply qualified dialysate,and precisely control the ultrafiltration volume.There were no significant differences in temperature,conductance,venous pressure and arterial pressure monitoring with the real time measured value by XL90 conductivity meter.Conclusions OBERS-3000 multifunctional hemodialysis machine can effectively eliminate uremic toxins,maintain electrolyte and acid-base balance,and can accurately display the monitoring parameters.