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

February 5, 2019 updated by: Spectral Diagnostics (US) Inc.

Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Victoria, British Columbia, Canada
    • Ontario
      • Oshawa, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Quebec City, Quebec, Canada
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Loma Linda, California, United States
      • San Diego, California, United States
      • Stanford, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Delaware
      • Newark, Delaware, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Georgia
      • Augusta, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Oak Park, Illinois, United States
      • Peoria, Illinois, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Kentucky
      • Hazard, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroit, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Jersey
      • Camden, New Jersey, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Greenville, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hypotension requiring vasopressor support
  • The subject must have received intravenous fluid resuscitation
  • Documented or suspected infection
  • Endotoxin Activity Assay ≥ 0.60 EAA units
  • Evidence of at least 1 new onset organ dysfunction

Exclusion Criteria:

  • Inability to achieve or maintain a minimum mean arterial pressure (MAP) of 65mmHg
  • Subject has end stage renal disease and requires chronic dialysis
  • There is clinical support for non-septic shock
  • Subject has had chest compressions as part of CPR
  • Subject has had an acute myocardial infarction (AMI)
  • Subject has uncontrolled hemorrhage
  • Major trauma within 36 hours of screening
  • Subject has severe granulocytopenia
  • HIV infection with a last known or suspected CD4 count of <50/mm3
  • Subject has sustained extensive third-degree burns
  • Body weight < 35 kg (77 pounds)
  • Known hypersensitivity to polymyxin B
  • Subject has known sensitivity or allergy to heparin
  • Subject has screening MOD score of ≤9

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
Standard medical care for septic shock
Other: Standard medical care for septic shock
Standard medical care for septic shock
Experimental: Treatment
Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock
Other: Standard medical care for septic shock
Standard medical care for septic shock
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 28 days
Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectral Diagnostics (US) Inc.

Investigators

  • Principal Investigator: Phillip Dellinger, Dr., Cooper Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2010

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 5, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDI-PMX-NA001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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