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NCT01046669 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
A NA study of Septic Shock and Endotoxemia, sponsored by Spectral Diagnostics (US).
- Completed
- Registry status
- NA
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT01046669: Completed NA study of Septic Shock and Endotoxemia, sponsored by Spectral Diagnostics (US).
NCT01046669 is a NA study of Septic Shock and Endotoxemia that has completed, run by Spectral Diagnostics (US). The registered enrollment target is 450 participants, below the 5,040-participant average among 24 other Septic Shock trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01046669, a NA study of Septic Shock and Endotoxemia, has completed, sponsored by Spectral Diagnostics (US).
- COMPLETED
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.
Primary Outcome
Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone
Conditions Studied
Interventions
- DEVICE TORAYMYXIN PMX-20R (PMX cartridge)
- OTHER Standard medical care for septic shock
Study Locations (20)
California
- - Loma Linda
- - San Diego
- - Stanford
Illinois
- - Oak Park
- - Peoria
Michigan
- - Ann Arbor
- - Detroit
Alabama
- - Birmingham
Arizona
- - Tucson
Arkansas
- - Little Rock
Colorado
- - Colorado Springs
Delaware
- - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2010-06 |
| Est. Completion | 2017-06 |
| Phase | NA |
What the finished NCT01046669 record still lists
NCT01046669 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 5,040-participant average among 24 other Septic Shock trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Septic Shock appearing as the primary indexed condition, and to 2 interventions - of which TORAYMYXIN PMX-20R (PMX cartridge) is the first listed.
NCT01046669 names 20 study sites across 16 states, led by California, Illinois, Michigan.
Frequently Asked Questions
What is clinical trial NCT01046669 about?
NCT01046669 is a clinical study titled "Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock". To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.
What is the current status of trial NCT01046669?
This trial is currently completed. It is a NA study. The enrollment target is 450 participants. The study started on 2010-06. Estimated completion is 2017-06.
What conditions does trial NCT01046669 study?
This clinical trial studies the following conditions: Septic Shock, Endotoxemia.
What interventions are being tested in trial NCT01046669?
The interventions under investigation include: TORAYMYXIN PMX-20R (PMX cartridge) (DEVICE), Standard medical care for septic shock (OTHER).
Who is sponsoring clinical trial NCT01046669?
This trial is sponsored by Spectral Diagnostics (US), which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01046669 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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 NCT01046669's enrollment target sits among peer trials
450 9th of 24 higher than 16 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
-
External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients
RECRUITING · NA
-
Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis
RECRUITING · NA
-
Assessment for Implementation Methods in Sepsis
RECRUITING · NA
-
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
RECRUITING · NA
-
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study
ACTIVE NOT RECRUITING · NA
-
Blood Purification for the Treatment of Pathogen Associated Shock
ACTIVE NOT RECRUITING · NA
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