A randomized controlled trial for the efficacy and safety of REXEEDTM series highflux dialyzer / 中华肾脏病杂志

ABSTRACT

Objective To evaluate the efficacy and safety of REXEEDTM series highflux dialyzer. Methods A randomized cross-over study of 3×3 Latin square was designed based on the surface area of dialyzer membrane (1.5 m2 and 2.1 m2). Seventy-two stable maintenance hemodialysis (MHD) patients from Shanghai Renji Hospital and Ruijin Hospital were enrolled in this study for 3 consecutive weeks. REXEEDTM-15AC, 15UC, 21AC, 21UC dialyzers were used as trial group and APS-15U,BIO-HX100 dialyzers were used as control group. The clearances of urea, creatinine, phosphorus and β2-microglobulin were calculated. Adverse event and adverse reactions were recorded. Results There were significantly higher urea and creatinine clearance in 1SAC and 15UC dialyzers as compared to APS-15U dialyzer [(222.07±18.74) mi/min, (220.23±26.26) ml/min vs (199.56±14.21) ml/min; (176.73±16.41) ml/min, (175.22±25.94) ml/min vs (165.42±14.68) ml/min, all P<0.05]. There were significantly higher urea, creatinine and β2-microglobulin clearance in 21AC and 21UC dialyzer as compared to BIO-HX100 dialyzer [(230.59±15.24) ml/min, (233.96±7.06) ml/min vs (203.43±36.66) ml/min; (183.50±25.90) ml/min, (181.05±23.94) ml/min vs (166.25±29.82) ml/min; (111.77±53.42) ml/min, (125.54±51.99) ml/min vs (42.39±4.81) ml/min; all P<0.05]. There was no significant difference of phosphorus clearance between REXEEDTM series dialyzers and control dialyzers. The efficiency of urea clearance and urea reduction ratio could achieve clinical targets in REXEEDTM series. Conclusion REXEEDTM series highflux dialyzers are effective and safe for clinical application.