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

Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock

Sponsors

Lead Sponsor: Spectral Diagnostics (US) Inc.

Source 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.

Overall Status Completed
Start Date 2010-06-01
Completion Date 2017-06-01
Primary Completion Date 2016-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mortality 28 days
Enrollment 450
Condition
Intervention

Intervention Type: Device

Intervention Name: TORAYMYXIN PMX-20R (PMX cartridge)

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).

Arm Group Label: Treatment

Intervention Type: Other

Intervention Name: Standard medical care for septic shock

Description: Standard medical care for septic shock

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Phillip Dellinger, Dr. Principal Investigator Cooper Health System
Location
Facility:
| 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, 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
| Saint 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
| Quebec City, Quebec, Canada
Location Countries

Canada

United States

Verification Date

2019-02-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control

Type: Sham Comparator

Description: Standard medical care for septic shock

Label: Treatment

Type: Experimental

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

Acronym EUPHRATES
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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