Despite decades of advancements, severe sepsis remains the leading cause of death in intensive care units. More than 200,000 deaths are reported annually in the United States as a result of sepsis.
The persistent high mortality of sepsis and septic shock has long been the driving force behind the search for new, more effective treatment options. Cooper University Hospital was recently selected as the national coordinating and flagship investigative center, for EUPHRATES, an innovative clinical trial featuring a novel device used to treat sepsis. EUPHRATES- Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock is under the direction of R. Phillip Dellinger, MD, Head of the Division of Critical Care Medicine and internationally renowned sepsis expert. With a target enrollment of 360 patients, plans are underway to expand EUPHRATES to include 15-20 U.S. locations in the coming year. Cooper faculty experience and expertise in sepsis treatment was a significant factor in the decision to select Cooper as the national center.
A double-blinded, randomized, controlled study sponsored by Spectral Diagnostics Inc., the clinical trial compares the safety and efficacy of combining hemoperfusion with a Polymyxin B cartridge and standard medical therapy for sepsis, versus standard medical therapy alone.
“Sepsis is a complex disorder that is difficult to define, difficult to diagnosis, and difficult to treat,” says Dr. Dellinger. “When septic shock is present, it is most often characterized as an overwhelming and at times lethal, systemic response to an infection. In many patients, part of that response is triggered by the release of bacterial endotoxins.”
Research has confirmed the link between elevated endotoxin levels and mortality in sepsis. This is the first sepsis trial ever, drug or device, to measure serum toxin levels and, when found to be elevated, specifically target removal.
Inclusion criteria for enrollment in EUPHRATES includes: documented or suspected infection, elevated endotoxin levels, presence of shock and evidence of at least one new-onset organ dysfunction.
“It is the most exciting new treatment option in decades, says Dr. Dellinger. “The outcome of EUPHRATES has the potential to change the way sepsis is treated and to make a significant impact on this still deadly disease.”
For more information about the EUPHRATES Trial, please call: 856.342.2633.