Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock

Inclusion Criteria: * Hypotension requiring vasopressor support * The subject must have received intravenous fluid resuscitation * Documented or suspected infection * Endotoxin Activity Assay ≥ 0.60 EAA units * Evidence of at least 1 new onset organ dysfunction Exclusion Criteria: * Inability to achieve or maintain a minimum mean arterial pressure (MAP) of 65mmHg * Subject has end stage renal disease and requires chronic dialysis * There is clinical support for non-septic shock * Subject has had chest compressions as part of CPR * Subject has had an acute myocardial infarction (AMI) * Subject has uncontrolled hemorrhage * Major trauma within 36 hours of screening * Subject has severe granulocytopenia * HIV infection with a last known or suspected CD4 count of \<50/mm3 * Subject has sustained extensive third-degree burns * Body weight \< 35 kg (77 pounds) * Known hypersensitivity to polymyxin B * Subject has known sensitivity or allergy to heparin * Subject has screening MOD score of ≤9