Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

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

FieldValue
Enrollment Target 450 participants
Start Date 2010-06
Est. Completion 2017-06
Phase NA

Sponsor

Spectral Diagnostics (US)

2 total trials

What the Registry Record Tells You About NCT01046669

The ClinicalTrials.gov registry entry for NCT01046669 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,040-participant average among 24 other Septic Shock trials with a reported enrollment target (91% lower). The listed sponsor is Spectral Diagnostics (US), which has 2 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.