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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Spectral Diagnostics (US) Inc. Identifier:
First received: January 8, 2010
Last updated: October 14, 2016
Last verified: June 2016
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.

Condition Intervention Phase
Septic Shock
Device: TORAYMYXIN PMX-20R (PMX cartridge)
Phase 3

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock

Resource links provided by NLM:

Further study details as provided by Spectral Diagnostics (US) Inc.:

Primary Outcome Measures:
  • Mortality [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • To compare mortality between the two groups at 90 days, 6 months and 12 months post-start of treatment [ Time Frame: 12 months ]

Enrollment: 450
Study Start Date: June 2010
Estimated Study Completion Date: June 2017
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control Device: 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).
Experimental: Treatment
Two (2) PMX cartridges will be administered approximately 24 hours apart.
Device: 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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01046669

  Show 40 Study Locations
Sponsors and Collaborators
Spectral Diagnostics (US) Inc.
Principal Investigator: Phillip Dellinger, Dr. Cooper Health System
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Spectral Diagnostics (US) Inc. Identifier: NCT01046669     History of Changes
Other Study ID Numbers: SDI-PMX-NA001
Study First Received: January 8, 2010
Last Updated: October 14, 2016

Additional relevant MeSH terms:
Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Polymyxin B
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 24, 2017