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