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

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

Conditions
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Septic Shock, Endotoxemia

Intervention / Treatment
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* Device: TORAYMYXIN PMX-20R (PMX cartridge)
* Other: Standard medical care for septic shock


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Standard medical care for septic shock | Other: Standard medical care for septic shock<br>* Standard medical care for septic shock<br>|
| Experimental: Treatment<br>Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock | Device: TORAYMYXIN PMX-20R (PMX cartridge)<br>* 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).<br>Other: Standard medical care for septic shock<br>* Standard medical care for septic shock<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone | 28 days |