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

Primary Purpose

Septic Shock, Endotoxemia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TORAYMYXIN PMX-20R (PMX cartridge)
Standard medical care for septic shock
Sponsored by
Spectral Diagnostics (US) Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Treatment

Arm Description

Standard medical care for septic shock

Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock

Outcomes

Primary Outcome Measures

Mortality
Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone

Secondary Outcome Measures

Full Information

First Posted
January 8, 2010
Last Updated
February 5, 2019
Sponsor
Spectral Diagnostics (US) Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01046669
Brief Title
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
Acronym
EUPHRATES
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2010 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectral Diagnostics (US) Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Endotoxemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Standard medical care for septic shock
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock
Intervention Type
Device
Intervention Name(s)
TORAYMYXIN PMX-20R (PMX cartridge)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Standard medical care for septic shock
Intervention Description
Standard medical care for septic shock
Primary Outcome Measure Information:
Title
Mortality
Description
Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip Dellinger, Dr.
Organizational Affiliation
Cooper Health System
Official's Role
Principal Investigator
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Loma Linda
State/Province
California
Country
United States
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San Diego
State/Province
California
Country
United States
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Stanford
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California
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United States
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Colorado Springs
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Colorado
Country
United States
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Newark
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Delaware
Country
United States
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Washington
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District of Columbia
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Idaho Falls
State/Province
Idaho
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United States
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Oak Park
State/Province
Illinois
Country
United States
City
Peoria
State/Province
Illinois
Country
United States
City
Iowa City
State/Province
Iowa
Country
United States
City
Hazard
State/Province
Kentucky
Country
United States
City
Baltimore
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Maryland
Country
United States
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Springfield
State/Province
Massachusetts
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
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Detroit
State/Province
Michigan
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United States
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Rochester
State/Province
Minnesota
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United States
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Jackson
State/Province
Mississippi
Country
United States
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Saint Louis
State/Province
Missouri
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Camden
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Greenville
State/Province
North Carolina
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
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Pittsburgh
State/Province
Pennsylvania
Country
United States
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Chattanooga
State/Province
Tennessee
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United States
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Houston
State/Province
Texas
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United States
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San Antonio
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Texas
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United States
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Richmond
State/Province
Virginia
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United States
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Calgary
State/Province
Alberta
Country
Canada
City
Edmonton
State/Province
Alberta
Country
Canada
City
Victoria
State/Province
British Columbia
Country
Canada
City
Oshawa
State/Province
Ontario
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Quebec City
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30470853
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.
Results Reference
derived
PubMed Identifier
30304428
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.
Results Reference
derived
PubMed Identifier
24916483
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.
Results Reference
derived

Learn more about this trial

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

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