The termination was made due to difficulties in recruiting subjects, despite modifying the inclusion criteria. The intended number of subjects was 32-44, but the included number of subjects according to protocol was only 8. Because of the low number of subjects recruited according to protocol, any observed differences between the Alteco LPS Adsorber and placebo device groups may be due to random variation. It is therefore not possible to draw any conclusions with respect to performance based on the data collected in this clinical investigation. Adverse event data, safety laboratory, vital sign and Richmond Agitation-Sedation Scale data provide no evidence of any risks associated with Alteco LPS Adsorber treatment.