Clinical trial NCT01046669: Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
Official title: Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Endotoxemia
Lead sponsor: Spectral Diagnostics (US) Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mortality
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Loma Linda
country: United States
state: California
city: San Diego
country: United States
state: California
city: Stanford
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Augusta
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Oak Park
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Hazard
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Camden
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Greenville
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Chattanooga
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Quebec City
country: Canada
state: Quebec
Study officials:
affiliation: Cooper Health System
name: Phillip Dellinger, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.