Open-label Evaluation of Polymyxin B Hemoperfusion for Septic Shock (EUPHORIA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02825329|
Expanded Access Status : Temporarily not available
First Posted : July 7, 2016
Last Update Posted : March 17, 2020
|Condition or disease||Intervention/treatment|
|Septic Shock Endotoxemia||Device: TORAYMYXIN PMX-20R|
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 Type :||Expanded Access|
|See clinical trials of the intervention/treatment in this expanded access record.|
|Official Title:||Evaluating the Use of Polymyxin B Hemoperfusion in a Prospective Non-controlled Trial in Adults|
- 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).