Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study

Prospective, multicenter, randomized, open-label study of standard of care plus the PMX cartridge versus standard of care alone in patients with endotoxemic septic shock

Inclusion Criteria: 1. Age ≥18 years of age 2. Hypotension requiring vasopressor support: Requirement for at least one of the vasopressors listed below, at the dose shown below, for at least 2 continuous hours and no more than 30 hours 1. Norepinephrine \> 0.05mcg/kg/min 2. Dopamine \> 10 mcg/kg/min 3. Phenylephrine \> 0.4 mcg/kg/min 4. Epinephrine \> 0.05 mcg/kg/min 5. Vasopressin \> 0.03 units/min 6. Vasopressin (any dose) in combination with another vasopressor listed above 3. The subject must have received intravenous fluid resuscitation of a minimum of 30mL/kg administered within 24 hours of eligibility 4. Documented or suspected infection defined as definitive or empiric intravenous antibiotic administration 5. The subject must have a screening multi-organ dysfunction score (MODS) \>9 OR a sequential organ failure assessment (SOFA) \>11, in the event a complete MODS cannot be obtained due to missing measurements 6. Endotoxin Activity Assay between ≥ 0.60 to \