Treatment with CytoSorb for cytokine removal in early septic shock shows improvement of clinical condition and inflammatory response
Berlin, Germany, February 14, 2019 – CytoSorbents Europe GmbH announces the publication of positive results of a randomized, controlled pilot study, proving a significant stabilization of the cardio-vascular system of patients who suffered from septic shock and have been treated with CytoSorb® as an early standalone (meaning without combined renal replacement) therapy for extracorporeal cytokine removal.
CytoSorb therapy is based on the first specifically-approved extracorporeal cytokine adsorber – CytoSorb 300 – marketed in the European Union and was designed to reduce the „cytokine storm“ or „cytokine release syndrome“ which is a major contributing factor in deadly inflammation. It is based on a cartridge containing biocompatible, highly porous polymer beads that act like sponges and actively remove harmful substances from the blood.
The pilot study will be published in the February issue of the Journal of Critical Care (49: 172-178) and can be accessed as an Epub under this link. It was authored by a medical team with the Department of Anesthesiology and Intensive Therapy of the University Szeged in Hungary, led by Professor Zsolt Molnar, a leading expert in the research and treatment of sepsis and septic shock. The team investigated the effects of a single treatment of extracorporeal cytokine removal with CytoSorb therapy, in addition to the standard treatments including, for example antibiotics, applied in patients with early stage septic shock (within the first 24 hours after onset of septic shock or after ICU admission). Twenty patients were randomized into a group treated with the CytoSorb therapy (n=10) for 24 hours or a control group (n=10). Clinical and laboratory data was recorded at the baseline and after 12, 24 and 48 hours.
The results show a significant decrease of Big-endothelin 1 (which is involved in the pathologic changes of the vascular system), procalcitonin (PCT) (an important marker of inflammation) and most importantly, norepinephrine doses needed to maintain sufficient cardio-vascular function – a vaso-constructive drug which is supposed to stabilize blood pressure but on the other hand reduces important oxygen supply to tissues as a side effect. The required norepinephrine doses dropped by almost 70% from baseline within 48 hours, in comparison to the group without CytoSorb. This result represents an important improvement for the patients.
The findings of this study demonstrate also that the most profound effects of CytoSorb therapy can take place in the first 12 hours of the treatment and the CytoSorb application could be tailored to the patients“ individual response and clinical course. However, different therapy doses might be useful for the patient, i.e., more than one CytoSorb treatment may be beneficial depending on the clinical situation.
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„Our results could serve as important milestones in designing future studies,“ said Professor Zsolt Molnar, the leading author of the study. „An important aspect in the design of this trial was our pragmatic approach, specifically, using only one adsorber per treated patient and the relatively short 48 hour observation period. Our target was to test the hypothesis that cytokine removal could have almost immediate effect on organ dysfunction and inflammatory response. This goal has been reached. In future, we can investigate which is the most sufficient CytoSorb dosage for the individual patient to provide the best personalized care.“
„We are pleased to learn about the final results of Professor Molnar and his team“s pilot study on treating refractory septic shock patients with CytoSorb therapy as a standalone hemoperfusion treatment before the onset of kidney dysfunction,“ said Dr. Jörg Scheier, Senior Medical Director Europe at CytoSorbents. „Professor Molnar“s work provides a significant contribution to the scientific evidence needed to demonstrate the treatment benefits of CytoSorb therapy and, at the same time the results will also be of great help in designing future, larger randomized multi centric trials with an even better definition of optimal patient characteristics and treatment modalities to maximize Cytosorb therapy effects.“
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in new technologies and therapies in intelligent blood purification. CytoSorbents Europe GmbH is a hundred percent daughter company of CytoSorbents Corporation and coordinates the introduction and commercialization of CytoSorbents products worldwide.
Its flagship product, CytoSorb® is the first specifically-approved extracorporeal cytokine absorber in the European Union and it is distributed in more than 50 countries worldwide. CytoSorb was designed to reduce the „cytokine storm“ or „cytokine release syndrome,“ which is a major element of the deadly inflammation often seen in critically-ill patients in the intensive care unit (ICU) and those undergoing complex open heart surgery. CytoSorbents“ purification technologies are based on biocompatible, highly porous polymer beads that act like sponges and actively remove harmful substances from the blood. CytoSorb has been used in more than 56,000 human treatments to date.
CytoSorbents technologies have received non-dilutive grant, contract, and other funding of approximately $25 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 (USSOCOM), 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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Phone: +49 89 41 77 61 -14
E-Mail: cytosorbents@lucyturpin.com
Url: http://www.lucyturpin.com
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Lucy Turpin Communications GmbH
Eva Hildebrandt
Prinzregentenstr. 89
81675 München
Phone: +49 89 41 77 61 -14
E-Mail: cytosorbents@lucyturpin.com
Url: http://www.lucyturpin.com
