Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
Information source: Spectral Diagnostics (US) Inc.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Septic Shock; Endotoxemia
Intervention: TORAYMYXIN PMX-20R (PMX cartridge) (Device)
Phase: Phase 3
Status: Recruiting
Sponsored by: Spectral Diagnostics (US) Inc. Official(s) and/or principal investigator(s):
Phillip Dellinger, Dr., Principal Investigator, Affiliation: Cooper Health System
Overall contact:
Debra Foster, Phone: 416.626.3233, Ext: 2001, Email: dfoster@spectraldx.com
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.
Clinical Details
Official title: Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mortality
Secondary outcome: To compare mortality between the two groups at 90 days, 6 months and 12 months post-start of treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Debra Foster, Phone: 416.626.3233, Ext: 2001, Email: dfoster@spectraldx.com
Birmingham, Alabama, United States; Recruiting
Edmonton, Alberta, Canada; Recruiting
Tucson, Arizona, United States; Recruiting
San Diego, California, United States; Recruiting
Colorado Springs, Colorado, United States; Recruiting
Orlando, Florida, United States; Recruiting
Idaho Falls, Idaho, United States; Recruiting
Peoria, Illinois, United States; Recruiting
Iowa City, Iowa, United States; Recruiting
Hazard, Kentucky, United States; Recruiting
Springfield, Massachusetts, United States; Recruiting
Rochester, Minnesota, United States; Recruiting
St. Louis, Missouri, United States; Recruiting
St.John's, Missouri, United States; Recruiting
Omaha, Nebraska, United States; Recruiting
Camden, New Jersey, United States; Recruiting
New York, New York, United States; Recruiting
Columbus, Ohio, United States; Recruiting
Toledo, Ohio, United States; Recruiting
Ottawa, Ontario, Canada; Not yet recruiting
Philadelphia, Pennsylvania, United States; Recruiting
Chattanooga, Tennessee, United States; Recruiting
Houston, Texas, United States; Recruiting
San Antonio, Texas, United States; Recruiting
Richmond, Virginia, United States; Recruiting
Additional Information
Starting date: June 2010
Last updated: January 16, 2013
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