Endotoxin removal: bringing the mission to North America.
The EUPHRATES trial (Evaluating Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock) is the first biomarker-driven trial in sepsis. This unique trial is being run in a blinded manner, further contributing to the robustness of its design. This paper will describe the implementation of the EUPHRATES trial focusing on 3 pertinent features: (1) managing (and maintaining) the blinding of a medical device trial; (2) impact of the use of a diagnostic test where eligible subjects with septic shock must also have high levels of endotoxin (≥ 0.60 EAA units), and (3) managing enrolment in a complicated trial design where two medical teams are involved (the intensivist as the blinded caregiver and nephrologists as the unblinded performers of the intervention). The study is nearing the halfway mark and is currently experiencing excellent recruitment success.
Spectral Diagnostics Inc., Toronto, Ont., Canada.
Debra
D
Foster
David J
DJ
Klein
Gualtiero
G
Guadagni
Paul M
PM
Walker
D000328:Adult; D000569:Americas; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D004731:Endotoxins / Q000097:blood / Q000302:isolation & purification*; D006464:Hemoperfusion / Q000379:methods*; D006801:Humans; D011112:Polymyxin B / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D018805:Sepsis / Q000097:blood / Q000175:diagnosis / Q000628:therapy*
D000900:Anti-Bacterial Agents; D004731:Endotoxins; D011112:Polymyxin B