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

Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock

To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.

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