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Open-label Evaluation of Polymyxin B Hemoperfusion for Septic Shock

NCT02825329 · Status: TEMPORARILY_NOT_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2021-09-14

No results posted yet for this study

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.

Conditions

  • Septic Shock
  • Endotoxemia

Interventions

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).

Sponsors & Collaborators

  • Spectral Diagnostics (US) Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02825329 on ClinicalTrials.gov