Can sterile and pyrogen-free on-line substitution fluid be routinely delivered? A multicentric study on the microbiological safety of on-line haemodiafiltration
L. Vaslaki et al., Can sterile and pyrogen-free on-line substitution fluid be routinely delivered? A multicentric study on the microbiological safety of on-line haemodiafiltration, NEPH DIAL T, 15, 2000, pp. 74-78
Background. Microbial contamination is characterized not only by the presen
ce of bacteria, but also by high concentrations of biologically active by-p
roducts. They are potentially able to cross ultrafiltration and dialysis me
mbranes and stimulate immunocompetent blood cells to synthesize cytokines.
In turn, cytokine induction causes acute symptoms and has been incriminated
in the long-term complications of haemodialysis patients. Infusion of larg
e volumes of substitution fluids following ultrafiltration of microbially c
ontaminated dialysis fluids may place patients on on-line therapies at part
icular risk.
Methods. In this study we evaluated 30 machines with a two-stage ultrafiltr
ation system in routine clinical haemodiafiltration settings in six centres
for 6 months. Microbiological safety was assessed monthly and at the last
use of the filters by determining microbial counts, endotoxin concentration
and cytokine-inducing activity.
Results. No pyrogenic episodes were observed during the study period. Doubl
e-filtration of standard dialysis fluid (range, <1-895 cfu/ml, 0.0028-4.682
2 IU/ml) resulted in sterile substitution fluids with endotoxin concentrati
ons well below the Ph.Eur. standard for haemofiltration solutions (range, 0
.0014-0.0281 vs 0.25 IU/ml). Moreover, they did not differ from commercial
haemofiltration solutions and depyrogenated saline. Likewise, there was no
difference in the cytokine inducing activity between the solutions tested.
The high microbiological quality of the ultrafiltered dialysis fluid, which
was in the same range as substitution fluid, translates into both the abse
nce of cytokine induction by dialyser back-transport and a redundant safety
mode of the on-line system by a second filtration step.
Conclusion. On-line HDF treatment can routinely be provided with ultra-pure
dialysis fluids and sterile substitution fluids at pyrogen-free levels. Th
e on-line preparation of substitution fluids thus can be considered microbi
ologically safe.