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

Completed · Not applicable

Conditions studied: Septic Shock, Endotoxemia

In brief

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.

Key facts

Study ID

NCT01046669

Run by

Spectral Diagnostics (US) Inc.

People needed

450

Starts

2010-06-01

Expected to finish

2017-06-01

Last updated by the study team

2019-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Loma Linda, California, United States
• Study site — San Diego, California, United States
• Study site — Stanford, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Newark, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Augusta, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Oak Park, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Hazard, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Jackson, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Camden, New Jersey, United States
• Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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