ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01046669
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Spectral Diagnostics (US) Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Septic Shock Endotoxemia Device: TORAYMYXIN PMX-20R (PMX cartridge) Not Applicable

Access to an investigational treatment associated with this study is temporarily not available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Actual Study Start Date : June 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arm Intervention/treatment
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).



Primary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046669


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Spectral Diagnostics (US) Inc.
ClinicalTrials.gov Identifier: NCT01046669     History of Changes
Other Study ID Numbers: SDI-PMX-NA001
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Shock
Shock, Septic
Endotoxemia
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Bacteremia
Toxemia
Polymyxins
Polymyxin B
Anti-Bacterial Agents
Anti-Infective Agents