๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-03-30

Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study (NCT03901807)

A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients With Endotoxemic Septic Shock

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Spectral Diagnostics (US) Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (20 Sites)

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

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Septic Shock clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—