Congratulations to Dr. Sugeet Jagpal and the RWJMS CRC for enrolling their first patient into the TIGRIS study! TIGRIS, sponsored by Spectral Diagnostics, looks at the efficacy and safety of the PMX cartridge for patients with endotoxemic septic shock.
ICU providers have long been frustrated by a lack of good therapeutic options for septic shock, which generally requires ICU admission and has a high mortality rate. The majority of cases of severe septic shock are associated with endotoxemia (i.e. the release of endotoxin, a component of gram negative bacteria, into the blood stream.) The TIGRIS study approaches endotoxemic shock in two ways:
1. Use of the Endotoxin Activity Assay (EAA) – patients with sepsis and suspected endotoxemia are screened for endotoxin using this assay via a kit supplied by the sponsor.
2. PMX Cartridge Hemoperfusion – patients with an endotoxin level between 0.6 to <0.9 units are eligible to be randomized to receive two extracorporeal hemoperfusion treatments using the PMX Cartridges plus standard of care vs. standard of care alone. The PMX Cartridges are treated with Polymyxin B, which adsorbs and removes endotoxin from the circulating blood.
The PMX Cartridges are investigational in the US, however, have been available in Japan and the EU for more than 20 years.
If you want to learn more about Endotoxemic shock and the TIGRIS study, you can tune in to an upcoming Lifetime show called The Balancing Act.