NCT01046669

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Spectral Diagnostics (US) Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock
• Endotoxemia

Interventions

Type	Name	Description
DEVICE	TORAYMYXIN PMX-20R (PMX cartridge)	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).
OTHER	Standard medical care for septic shock	Standard medical care for septic shock

Timeline

• Start date: 2010-06-01
• Primary completion: 2016-07-01
• Completion: 2017-06-01
• First posted: 2010-01-12
• Last updated: 2019-02-26
• Results posted: 2019-02-06

Locations

40 sites across 2 countries: United States, Canada