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

Running, not enrolling · Not applicable

Conditions studied: Septic Shock, Endotoxemia

In brief

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

Key facts

Study ID

NCT03901807

Run by

Spectral Diagnostics (US) Inc.

People needed

150

Starts

2020-01-09

Expected to finish

2026-04-30

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• University of California, San Francisco — San Francisco, California, United States
• Pulmonary Associates — Boulder, Colorado, United States
• George Washington University — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Louisiana State University Health Shreveport — Shreveport, Louisiana, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Cooper Health System — Camden, New Jersey, United States
• Rutgers, The State University of New Jersey — Piscataway, New Jersey, United States
• Mt Sinai Hospital — New York, New York, United States
• Stony Brook University — Stony Brook, New York, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• CHI Memorial — Chattanooga, Tennessee, United States
• Parkridge Hospital — Chattanooga, Tennessee, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• Institute for Extracorporeal Life Support — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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