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Open-label Evaluation of Polymyxin B Hemoperfusion for Septic Shock — EUPHORIA  

Septic Shock Clinical Trial

Official title:
Evaluating the Use of Polymyxin B Hemoperfusion in a Prospective Non-controlled Trial in Adults

Clinical Trial Summary

Open-label, non-controlled study of standard care plus the TORAYMYXIN PMX-20R (PMX cartridge) in subjects who have endotoxemia and septic shock. This is a continued access study subsequent to the EUPHRATES clinical trial NCT01046669.

Clinical Trial Description

This is an open-label, non-controlled trial of standard medical care plus the TORAYMYXIN PMX-20R (PMX cartridge), in subjects with endotoxemia and septic shock. Subjects in ICUs will be assessed for septic shock using known or suspected infection and hypotension requiring vasopressor support as primary criteria. Endotoxemia will be assessed using the Endotoxin Activity Assay. Consented eligible subjects will receive two interventions with the PMX cartridge approximately 24 hours apart.The status of all subjects will be followed for 28 days, and long term follow-ups completed at 3 months, 6 months and 12 months. This is a continued access study subsequent to the EUPHRATES clinical trial NCT01046669. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02825329
Study type Expanded Access
Source Spectral Diagnostics (US) Inc.
Contact
Status Temporarily not available
Phase
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