NCT02825329

Open-label Evaluation of Polymyxin B Hemoperfusion for Septic Shock

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

• Status: Temporarily Not Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Spectral Diagnostics (US) Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Septic Shock
• Endotoxemia

Interventions

Type	Name	Description
DEVICE	TORAYMYXIN PMX-20R	Two (2) PMX cartridges will be administered approximately 24 hours apart. PMX Cartridge is an 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).

Timeline

• First posted: 2016-07-07
• Last updated: 2021-09-14