Heute geht es um diese Studie:
und folgende Pressemeldung:
„MONMOUTH JUNCTION, N.J., Sept. 25, 2019 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, highlights a new publication entitled, „Hemoadsorption with CytoSorb shows a decreased observed versus expected 28-day all-cause mortality in ICU patients with septic shock: a propensity-score-weighted retrospective study,“ in the journal Critical Care.
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.
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.
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.“
Der Direktvertrieb in den Niederlanden steht. Wie viel Spaß muss es machen, mit so einer Studie den Vertrieb anzukurbeln? Übrigens wurde der Adsorber in dieser Studie nur alle 24 Stunden gewechselt. Bei einer Reihe von Patienten wurde der Adsorber zudem recht spät eingesetzt (angeblich ohne Auswirkungen auf die Studie). Ich bin aber mal so frei und behaupte, dass man mit einem Adsorber-Wechsel alle 4 – 12 Stunden und einem frühzeitigen Einsatz deutlich mehr Menschen das Leben retten kann und tippe hier auf noch mal 10 % obendrauf. Das wären dann rund 30 % weniger Sepsis-Tote im Vergleich zu einer Standardtherapie, wobei ich die 19 % natürlich auch schon sehr beachtlich finde.