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Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
Recruiting
I'm InterestedTrial ID: NCT01046669
Purpose
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.
Official Title
Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock
Stanford Investigator(s)
Ronald Pearl
Dr. Richard K. and Erika N. Richards Professor
Javier Lorenzo
Clinical Associate Professor, Anesthesiology, Perioperative and Pain Medicine
Eligibility
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
Intervention(s):
device: TORAYMYXIN PMX-20R (PMX cartridge)
other: Standard medical care for septic shock
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Valerie Ojha
498-6210