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Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study
NCT03901807 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- DEVICE Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge
Study Locations (20)
New Jersey
- Cooper Health System — Camden
- Rutgers, The State University of New Jersey — Piscataway
New York
- Mt Sinai Hospital — New York
- Stony Brook University — Stony Brook
Tennessee
- CHI Memorial — Chattanooga
- Parkridge Hospital — Chattanooga
Texas
- The University of Texas Health Science Center at Houston — Houston
- Institute for Extracorporeal Life Support — San Antonio
Alabama
- University of Alabama at Birmingham — Birmingham
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
California
- University of California, San Francisco — San Francisco
Colorado
- Pulmonary Associates — Boulder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-01-09 |
| Est. Completion | 2026-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03901807
The ClinicalTrials.gov registry entry for NCT03901807 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spectral Diagnostics (US), which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Septic Shock appearing as the primary indexed condition, and to 1 intervention — of which Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03901807 reports 20 study locations spanning 16 distinct geographic areas — top geographies include New Jersey, New York, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03901807 about?
NCT03901807 is a clinical study titled "Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study". 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
What is the current status of trial NCT03901807?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2020-01-09. Estimated completion is 2026-04-30.
What conditions does trial NCT03901807 study?
This clinical trial studies the following conditions: Septic Shock, Endotoxemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03901807?
The interventions under investigation include: Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03901807?
This trial is sponsored by Spectral Diagnostics (US), which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03901807 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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