METHODS: We conducted an 8-week randomized crossover study on 16 Hemodialysis machines to compare CCS versus PPC. Performance is assessed by solute concentrations while safety is assessed by microbial count, endotoxin level and adverse event reporting.

RESULTS: Microbial counts and endotoxin levels were monitored on 48 occasions during the 8-week study for the CCS arm of the study. The levels were all below the action limit during the study. No patient reported any adverse events. Dialysate Sodium, Chloride and Bicarbonate concentrations were measured on a total of 128 occasions for each arm of the study. The relative deviations of Sodium, Chloride and Bicarbonate concentration were within ±5% of their nominal values for both. The 95% Confidence Intervals for the ratio of the mean solute concentrations on the CCS to PPC lie within the tolerance limit of ±5%.