Open Actively Recruiting

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


Brief Summary

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

Primary Purpose
Study Type
Phase 3


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

Inclusion Criteria:

  • Age ≥18 years of age
  • 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
    • Norepinephrine > 0.05mcg/kg/min
    • Dopamine > 10 mcg/kg/min
    • Phenylephrine > 0.4 mcg/kg/min
    • Epinephrine > 0.05 mcg/kg/min
    • Vasopressin > 0.03 units/min
    • Vasopressin (any dose) in combination with another vasopressor listed above
  • The subject must have received intravenous fluid resuscitation of a minimum of 30mL/kg administered within 24 hours of eligibility
  • Documented or suspected infection defined as definitive or empiric intravenous antibiotic administration
  • 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
  • Endotoxin Activity Assay between ≥ 0.60 to <0.90 EA units
  • Evidence of at least 1 of the following criteria for new onset organ dysfunction that is considered to be due to the acute illness:
    • Requirement for positive pressure ventilation via an endotracheal tube or tracheostomy tube
    • Thrombocytopenia defined as acute onset of platelet count <150,000µ/L or a reduction of 50% from prior known levels
    • Acute oliguria defined as urine output <0.5mL/kg/hr for at least 6 hours despite adequate fluid resuscitation

Exclusion Criteria:

  • Inability to obtain an informed consent from the subject, family member or an authorized surrogate
  • Lack of commitment for full medical support
  • Inability to achieve or maintain a minimum mean arterial pressure (MAP) of ≥ 65mmHg despite vasopressor therapy and fluid resuscitation
  • Subject has end-stage renal disease and requires chronic dialysis
  • There is clinical support for non-septic shock such as:
    • Acute pulmonary embolus
    • Transfusion reaction
    • Severe congestive heart failure (e.g. NYHA Class IV, ejection fraction < 35%)
  • Subject has had chest compressions as part of CPR during this hospitalization without immediate return to communicative state
  • Subject has had an acute myocardial infarction (AMI) within the past 4 weeks
  • Subject has uncontrolled hemorrhage (acute blood loss requiring > 3 UPC in the past 24 hours)
  • Major trauma within 36 hours of screening
  • Subject has severe granulocytopenia (leukocyte count less than 500 cells/mm3) or severe thrombocytopenia (platelet count less than 30,000 cells/mm3)
  • HIV infection in association with a last known or suspected CD4 count of <50/mm3
  • Subject's baseline state is non-communicative
  • Subject has sustained extensive third-degree burns within the past 7 days
  • Body weight < 35 kg (77 pounds)
  • Known hypersensitivity to Polymyxin B
  • Subject has known sensitivity or allergy to heparin or has a history of heparin associated thrombocytopenia (H.I.T.)
  • Subject is currently enrolled in an investigational drug or device trial
  • Subject has been previously enrolled in the current trial
  • Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate for enrollment, such as end-stage chronic illness (eg. lack of source control and bowel necrosis) with no reasonable expectation of survival to hospital discharge

Join this Trial

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Study Stats
Protocol No.
Blood Disorders
Jennifer Scovotti
  • UCLA Westwood
For Providers
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