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

Spectral Diagnostics

Status: Completed

Conditions: Endotoxemia; Septic Shock

Treatments: Device: TORAYMYXIN PMX-20R (PMX cartridge); Other: Standard medical care for septic shock

Study type: Interventional

Funder types: Industry

Identifiers

NCT01046669

SDI-PMX-NA001

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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450 participants in 2 patient groups

Control

Sham Comparator group

Description:

Standard medical care for septic shock

Treatment:

Other: Standard medical care for septic shock

Treatment

Experimental group

Description:

Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock

Treatment:

Other: Standard medical care for septic shock

Device: TORAYMYXIN PMX-20R (PMX cartridge)