In Vitro Biocompatibility of a Heat -Sterilized, Low Toxic, and Less Acidic Fluid for Peritoneal Dialysis

Author:

Wieslander Anders P.12,Deppisch Reinhold3,Svensson Eva1,Forsbäck Gunita1,Speidel Rose3,Rippe Bengt2

Affiliation:

1. Department of Regulatory Affairs and Preclinical Research, Gambro Lundia AB, Lund, Sweden

2. Department of Nephrology, University Hospital of Lund, Lund, Sweden

3. Research Department, Gambro Hechingen, Germany

Abstract

Objective The aim of this study was to investigate a peritoneal dialysis (PD) fluid (PD-Bio), produced with the intention of reducing the amount of glucose degradation products and to increase the final pH. The heat sterilization of the fluid was performed with the glucose separated from the electrolytes. After sterilization the two solutions were combined. Methods The in vitro biocompatibility of PD-Bio was measured as the inhibition of cell growth of a cultured fibroblast cell line and as the stimulated release of interleukin-1β from cultured human mononuclear cells. The glucose degradation products were measured as UV absorbance at 228 nm or 284 nm and the concentration of aldehydes was estimated with high-performance liquid chromatography and gas chromatography. Results Our results demonstrate that in comparison to conventional PD fluids the pH of PD-Bio was increased, to about 6.5. Due to less contaminating glucose degradation products in PD-Bio, basal cytotoxicity was significantly decreased for both 1.5% and 4% glucose-containing fluids, and the stimulated release of interleukin-1β was normalized compared to sterile filtered controls with the same pH. UV absorbance measured at 228 nm was decreased, whereas the absorbance at 284 nm was equal to that of a conventional fluid. In PD-Bio the concentrations of formaldehyde, acetaldehyde, methylglyoxal, and 2-furaldehyde were found to be below the detection limit, whereas glyoxal was present in the same and 5hydroxymethylfurfural (5-HMF) in higher concentrations than in conventionally produced PD fluid. Conclusions The results demonstrate that it is possible to improve biocompatibility of PD fluids by simply changing the way the fluid is produced.

Publisher

SAGE Publications

Subject

Nephrology,General Medicine

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