Study failed to confirm benefit of novel treatment used in many countries worldwide
The results of a five-year, international multicenter trial studying the efficacy of a “blood purification” technique to treat sepsis has been published today in The Journal of the American Medical Association, a leading medical journal. Cooper University Health Care was the flagship investigative center and also the coordinating center for the study.
The study detailed in the paper (Effect of targeted polymyxin B hemoperfusion on 28-day mortality in patients with septic shock and elevated endotoxin level: the EUPHRATES randomized clinical trial) failed to confirm a beneficial treatment effect of polymyxin-B hemoperfusion in patients with sepsis.
Polymyxin-B hemoperfusion is a blood purification technique designed to bind and neutralize a circulating bacterial toxin (endotoxin) that is often found in high levels in sepsis patients.
“Sepsis is the number one cause of death in hospitalized patients. This study continues to add to the disappointing results of potential innovative therapies that directly target this condition where there have been no successes and currently only organ support therapies exist to treat sepsis patients,” said R. Philip Dellinger, MD, FCCM, FCCP, a critical care medicine specialist at Cooper, who served as lead author on the paper. Dr. Dellinger is a globally recognized expert in sepsis. “Although the intervention failed to improve outcome, it still provides valuable scientific information in understanding this devastating disease process that claims a life every three to four seconds worldwide,” he said.
The study was significant since the treatment is currently approved and widely used in several countries around the world including Japan. More than 450 patients at 55 tertiary hospitals in the United States and Canada were enrolled in the double-blinded study. One group of patients received polymyxin-B hemoperfusion along with conventional treatment while the other group received conventional therapy alone. Patients were only enrolled in the study if they had high levels of the toxin measured in the blood (i.e. theragnostics, a term that blends “therapy” with a “diagnostic” test that the therapy targets).
The additional treatment did not reduce mortality in patients.
In addition to Dr. Dellinger, co-authors of the publication included Cooper researchers Stephen Trzeciak, MD, MPH, interim chief of medicine; Lawrence S. Weisberg, MD, FACP, head of the Division of Nephrology, and Christa Schorr, DNP, RN, MSN, clinical nurse scientist and sepsis expert.
Wendy A. Marano
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