BACKGROUND: The aim of this study was to investigate in vitro biocompatibility of Reguneal™, a new bicarbonate containing peritoneal dialysis fluid (PDF) for Japan, and compare it with other PDFs available in that country. METHODS: We assessed basal cytotoxicity using in vitro proliferation of cultured fibroblasts, L-929, determining the quantity of living cells by the uptake of Neutral Red. Levels of ten glucose degradation products (GDPs) were measured by a validated ultrahigh-performance liquid chromatography method in combination with an ultraviolet detector. We compared inhibition of fibroblast cell growth between brands of PDF, adjusting for dextrose and GDP concentrations using random-effects mixed models. RESULTS: The results demonstrate that cytotoxicity of Reguneal™ is comparable to a sterile-filtered control and is less cytotoxic than most of the other PDFs, most of which significantly inhibited cell growth. As a "class effect", increasing dextrose and GDP concentrations were non-significantly but positively associated with cytotoxicity. As a "brand effect", these relationships varied widely between brands, and some PDFs had significant residual effects on basal cytotoxicity through mechanisms that were unassociated with either dextrose or GDP concentration. CONCLUSION: Our study suggests that Reguneal™ is a biocompatible PDF. The results of our study also highlight that dextrose and GDPs are important for biocompatibility, but alone are not a complete surrogate. The results of our study need to be confirmed in other tissue culture models, and should lead to further research on determinants of biocompatibility and the effect of such PDFs on clinical outcomes.
BACKGROUND: The aim of this study was to investigate in vitro biocompatibility of Reguneal™, a new bicarbonate containing peritoneal dialysis fluid (PDF) for Japan, and compare it with other PDFs available in that country. METHODS: We assessed basal cytotoxicity using in vitro proliferation of cultured fibroblasts, L-929, determining the quantity of living cells by the uptake of Neutral Red. Levels of ten glucose degradation products (GDPs) were measured by a validated ultrahigh-performance liquid chromatography method in combination with an ultraviolet detector. We compared inhibition of fibroblast cell growth between brands of PDF, adjusting for dextrose and GDP concentrations using random-effects mixed models. RESULTS: The results demonstrate that cytotoxicity of Reguneal™ is comparable to a sterile-filtered control and is less cytotoxic than most of the other PDFs, most of which significantly inhibited cell growth. As a "class effect", increasing dextrose and GDP concentrations were non-significantly but positively associated with cytotoxicity. As a "brand effect", these relationships varied widely between brands, and some PDFs had significant residual effects on basal cytotoxicity through mechanisms that were unassociated with either dextrose or GDP concentration. CONCLUSION: Our study suggests that Reguneal™ is a biocompatible PDF. The results of our study also highlight that dextrose and GDPs are important for biocompatibility, but alone are not a complete surrogate. The results of our study need to be confirmed in other tissue culture models, and should lead to further research on determinants of biocompatibility and the effect of such PDFs on clinical outcomes.
Authors: Edwina A Brown; Wim Van Biesen; Fredric O Finkelstein; Helen Hurst; David W Johnson; Hideki Kawanishi; Roberto Pecoits-Filho; Graham Woodrow Journal: Perit Dial Int Date: 2009 Nov-Dec Impact factor: 1.756
Authors: Janusz Witowski; Katarzyna Korybalska; Justyna Wisniewska; Andrzej Breborowicz; Gerhard M Gahl; Ulrich Frei; Jutta Passlick-Deetjen; Achim Jörres Journal: J Am Soc Nephrol Date: 2000-04 Impact factor: 10.121
Authors: P Kjellstrand; E Martinson; A Wieslander; K Kjellstrand; E Jeppsson; E Svensson; L Järkelid; T Linden; L F Olsson Journal: Perit Dial Int Date: 2001 Jul-Aug Impact factor: 1.756
Authors: Llinos W Morgan; Anders Wieslander; Malcolm Davies; Takashi Horiuchi; Yuji Ohta; M Janine Beavis; Kathryn J Craig; John D Williams; Nicholas Topley Journal: Kidney Int Date: 2003-11 Impact factor: 10.612