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NCT03901807 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study
A NA study of Septic Shock and Endotoxemia, sponsored by Spectral Diagnostics (US).
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT03901807: Active NA study of Septic Shock and Endotoxemia, sponsored by Spectral Diagnostics (US).
NCT03901807 is a NA study of Septic Shock and Endotoxemia that is active but no longer recruiting, run by Spectral Diagnostics (US). The registered enrollment target is 150 participants, below the 5,053-participant average among 24 other Septic Shock trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03901807, a NA study of Septic Shock and Endotoxemia, is active but no longer recruiting, sponsored by Spectral Diagnostics (US).
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
The primary objective is to compare the safety and efficacy of the PMX cartridge (Toraymyxin) based on mortality at 28 days in patients with septic shock and endotoxemia who are treated with standard medical care plus the use of the PMX cartridge, versus patients who receive standard medical care alone.
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 |
What the registry record for NCT03901807 still lists
NCT03901807 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 5,053-participant average among 24 other Septic Shock trials with a reported enrollment target (97% lower).
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.
NCT03901807 names 20 study sites across 16 states, led by New Jersey, New York, Tennessee.
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.
What interventions are being tested in trial NCT03901807?
The interventions under investigation include: Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge (DEVICE).
Who is sponsoring clinical trial NCT03901807?
This trial is sponsored by Spectral Diagnostics (US), which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Septic Shock
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03901807's enrollment target sits among peer trials
150 13th of 24 higher than 11 of 24 other Septic Shock trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Septic Shock trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients
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-
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Assessment for Implementation Methods in Sepsis
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Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
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Blood Purification for the Treatment of Pathogen Associated Shock
ACTIVE NOT RECRUITING · NA
-
Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock
COMPLETED · NA
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