N/A
N=450
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
Septic Shock · Endotoxemia
Bottom Line
View on ClinicalTrials.gov: NCT01046669 ↗Enrolled (actual)
450
Serious AEs
61.6%
Results posted
Feb 2019
Primary outcome: Primary: Mortality — 78; 84 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TORAYMYXIN PMX-20R (PMX cartridge) (Device); Standard medical care for septic shock (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spectral Diagnostics (US) Inc.
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality |
78; 84 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01046669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.