Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
EUPHRATES
Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock
1 other identifier
interventional
450
2 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2010
Longer than P75 for not_applicable
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2010
CompletedFirst Posted
Study publicly available on registry
January 12, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
February 6, 2019
CompletedFebruary 26, 2019
February 1, 2019
6.1 years
January 8, 2010
October 24, 2018
February 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality
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
Study Arms (2)
Control
SHAM COMPARATORStandard medical care for septic shock
Treatment
EXPERIMENTALTwo (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Loma Linda, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Stanford, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Newark, Delaware, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Idaho Falls, Idaho, United States
Unknown Facility
Oak Park, Illinois, United States
Unknown Facility
Peoria, Illinois, United States
Unknown Facility
Iowa City, Iowa, United States
Unknown Facility
Hazard, Kentucky, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
Jackson, Mississippi, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Camden, New Jersey, United States
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New York, New York, United States
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Greenville, North Carolina, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Chattanooga, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Calgary, Alberta, Canada
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Oshawa, Ontario, Canada
Unknown Facility
Ottawa, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Québec, Quebec, Canada
Related Publications (3)
Klein DJ, Foster D, Walker PM, Bagshaw SM, Mekonnen H, Antonelli M. Polymyxin B hemoperfusion in endotoxemic septic shock patients without extreme endotoxemia: a post hoc analysis of the EUPHRATES trial. Intensive Care Med. 2018 Dec;44(12):2205-2212. doi: 10.1007/s00134-018-5463-7. Epub 2018 Nov 23.
PMID: 30470853DERIVEDDellinger RP, Bagshaw SM, Antonelli M, Foster DM, Klein DJ, Marshall JC, Palevsky PM, Weisberg LS, Schorr CA, Trzeciak S, Walker PM; EUPHRATES Trial Investigators. Effect of Targeted Polymyxin B Hemoperfusion on 28-Day Mortality in Patients With Septic Shock and Elevated Endotoxin Level: The EUPHRATES Randomized Clinical Trial. JAMA. 2018 Oct 9;320(14):1455-1463. doi: 10.1001/jama.2018.14618.
PMID: 30304428DERIVEDKlein DJ, Foster D, Schorr CA, Kazempour K, Walker PM, Dellinger RP. The EUPHRATES trial (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock): study protocol for a randomized controlled trial. Trials. 2014 Jun 11;15:218. doi: 10.1186/1745-6215-15-218.
PMID: 24916483DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Debra Foster, VP Clinical Development
- Organization
- Spectral Diagnostics Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Phillip Dellinger, Dr.
Cooper Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2010
First Posted
January 12, 2010
Study Start
June 1, 2010
Primary Completion
July 1, 2016
Study Completion
June 1, 2017
Last Updated
February 26, 2019
Results First Posted
February 6, 2019
Record last verified: 2019-02