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

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