Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
NCT ID: NCT01046669
Last Updated: 2019-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
450 participants
INTERVENTIONAL
2010-06-30
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control
Standard medical care for septic shock
Standard medical care for septic shock
Standard medical care for septic shock
Treatment
Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock
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).
Standard medical care for septic shock
Standard medical care for septic shock
Interventions
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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).
Standard medical care for septic shock
Standard medical care for septic shock
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Spectral Diagnostics (US) Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Phillip Dellinger, Dr.
Role: PRINCIPAL_INVESTIGATOR
Cooper Health System
Locations
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Birmingham, Alabama, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Loma Linda, California, United States
San Diego, California, United States
Stanford, California, United States
Colorado Springs, Colorado, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Augusta, Georgia, United States
Idaho Falls, Idaho, United States
Oak Park, Illinois, United States
Peoria, Illinois, United States
Iowa City, Iowa, United States
Hazard, Kentucky, United States
Baltimore, Maryland, United States
Springfield, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Rochester, Minnesota, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Camden, New Jersey, United States
New York, New York, United States
Greenville, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Chattanooga, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Victoria, British Columbia, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Québec, Quebec, Canada
Countries
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References
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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.
Dellinger 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.
Klein 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.
Other Identifiers
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SDI-PMX-NA001
Identifier Type: -
Identifier Source: org_study_id
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