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The BioStat 1000 is a new device which employs dialysate-based urea kinetics to calculate the dose of dialysis (Kt/V) based on a two-pool model and protein catabolic rate (PCR). Previous methods relying on blood sampling techniques were subject to error and difficult to implement. This paper describes the features of the Biostat and the results of the first clinical validation study with an early prototype. The BioStat was found to compare favorably with the reference method of direct dialysate quantification (mDDQ) which had been modified to obtain a "two-pool" Kt/V. In 31 patients no significant difference was found between mean Kt/V from the mDDQ and the mean Kt/V from the BioStat (1.35 +/- 0.33 versus 1.38 +/- 0.36, respectively). The PCR was also not significantly different (53.4 +/- 18.5 g/day versus 51.8 +/- 16 g/day, respectively). The BioStat was demonstrated to be a convenient method producing reliable results.

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