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Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock

NCT01046669 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2019-02-26

Study results available
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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

  • Septic Shock
  • Endotoxemia

Interventions

DEVICE

TORAYMYXIN PMX-20R (PMX cartridge)

TORAYMYXIN PMX-20R (PMX cartridge), Extracorporeal hemoperfusion device. Each treatment will target 2 hours with a minimum of 1 ½ hours, at a flow rate of approximately 100 ml/minute, (range of 80 to 120 ml/minute).

OTHER

Standard medical care for septic shock

Standard medical care for septic shock

Sponsors & Collaborators

  • Spectral Diagnostics (US) Inc.

    lead INDUSTRY

Principal Investigators

  • Phillip Dellinger, Dr. · Cooper Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2016-07-31
Completion
2017-06-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01046669 on ClinicalTrials.gov