Patients treated with standard of care and CytoSorb had a statistically significant reduction in 28-day all-cause mortality compared to standard of care alone (53% vs 72% control, p<0.04), based on the sIPTW analysis. In addition, observed 28-day all-cause mortality in the CytoSorb treatment group was significantly lower than the predicted mortality (48% observed vs 75% predicted, p<0.001), based on SOFA score.
In this study, clinical researchers at Maasstad Hospital and at Erasmus University Medical Center in Rotterdam, Netherlands conducted a retrospective evaluation of 116 patients with septic shock, who required vasopressors to increase their blood pressure, and renal replacement therapy (RRT) due to kidney failure. Of these, 49 patients received standard of care therapy, and 67 were treated with standard of care plus CytoSorb. Both groups were compared by stabilized Inverse Probability of Treatment Weights (sIPTW) to overcome baseline differences in the type of sepsis, age, comorbidities, surgery vs no surgery, Sequential Organ Failure Assessment (SOFA) score, use of the vasopressor noradrenaline, and lactate levels.
Dr. Willem P. Brouwer, MD PhD, from Erasmus University Medical Center and Maasstad Hospital, and lead author of the study stated, "To our knowledge, this study represents the largest published cohort of septic shock patients treated with CytoSorb therapy in which mortality was assessed as a primary outcome. We have demonstrated compelling evidence that CytoSorb, when added to standard continuous renal replacement therapy (CRRT), improved 28-day mortality in our patients with septic shock compared to CRRT alone. These findings significantly strengthen the current body of clinical evidence that demonstrate the benefit of CytoSorb in treating sepsis. The results are particularly relevant given that sepsis and septic shock kill more than 6 million people annually around the world, even in countries with high standards of medical care, making it the leading cause of mortality worldwide. Without effective therapies, the numbers of deaths from sepsis continue to rise due to aging populations, increasing co-morbidities, and antibiotic resistant pathogens. We may now have a new treatment option with CytoSorb."
Principal Investigator Professor Dr. Can Ince, Erasmus University Medical Center Rotterdam, underscored, "Given our results, CytoSorb therapy seems to have a great future for the treatment of septic shock. In addition to the significant improvement in survival, we were impressed with the safety profile of this therapy. In our study, no device related adverse events could be observed, which is remarkable as the treated ICU patients were very severely-ill and complex."
Dr. Joerg Scheier, Senior Medical Director at CytoSorbents Europe, stated, "This important independent, investigator-initiated study suggests the sole addition of CytoSorb to standard of care could potentially save 19 additional lives out of every 100 patients with septic shock and kidney failure, compared to standard of care therapy alone. Previous data on a potential survival benefit for CytoSorb patients are now confirmed for the first time versus a control group. These are not just statistics, but a real-world, positive impact on patients and their families in one of the most deadly illnesses today."
Sepsis is a medical emergency that results from of an overzealous immune response to a serious infection, driven by a "cytokine storm", leading to widespread deadly inflammation that can cause multiple organ failure, immune paralysis, and death. According to the Global Sepsis Alliance, sepsis afflicts approximately 27 to 30 million people each year worldwide, and kills someone every few seconds, despite the use of antibiotics.
CytoSorb® blood purification works to control the excessive inflammatory response through cytokine reduction, removal of bacterial toxins, and redirection of activated white blood cells to the area of infection and away from healthy organs. In doing so, the goal of CytoSorb is to prevent or treat organ failure, the leading cause of death in sepsis. CytoSorb is approved in the European Union and distributed in 58 countries around the world. CytoSorb is not yet approved in the U.S.
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to reduce inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorbents is conducting its pivotal REFRESH 2-AKI trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. CytoSorb® has been used in more than 67,000 human treatments to date.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of nearly $26 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
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