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

Launched by SPECTRAL DIAGNOSTICS (US) INC. · Jan 11, 2010

Keywords

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Gender

ALL

Eligibility criteria

• 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

Trial Officials