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

Not Applicable

Completed

• Conditions: Septic Shock; Endotoxemia
• Interventions: Other: Standard medical care for septic shock; Device: TORAYMYXIN PMX-20R (PMX cartridge)

• Registration Number: NCT01046669
• Lead Sponsor: Spectral Diagnostics (US) Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Study Start: 2010-06
• Primary Completion: 2016-07
• Study Completion: 2017-06
• Results First Submitted: 2018-10-24
• Results First Submitted QC: 2019-01-16
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-05
• Results First Posted: 2019-02-06
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard medical care for septic shock	Standard medical care for septic shock
Treatment	TORAYMYXIN PMX-20R (PMX cartridge)	Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock
Treatment	Standard medical care for septic shock	Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock

Primary Outcome Measures

Name	Time	Method
Mortality	28 days	Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone