Event review

Successful 4th International CytoSorb Users Meeting 2017

The day before the start of the 37th ISICEM, the 4th International Users Meeting brought together 120 CytoSorb users and other interested parties from a total of 22 countries. The international faculty shared an update on the latest scientific findings, recent study results and case series in different patient groups, followed by a podium discussion. Between the lectures the participants could benefit from the possibility to exchange their experiences made with the CytoSorb therapy. To date, CytoSorb therapy has been used in more than 20,000 human treatments in more than 450 hospitals around the world. 

Presentations

International registry on the use of the CytoSorb®-Adsorber in ICU patients (NCT02312024) – study protocol and preliminary results

Brunkhorst M. F.

CytoSorb in early septic shock – The ACESS trial

Molnár Z.

Clinical experience with CytoSorb in sepsis: A 30 patients case series

Mitzner S.

Clinical experiences in endocarditis - An intraoperative case series

Träger K.

Continuous Hemodiafiltration with a Cytokine-Adsorber During Sepsis

Houschyar K.

New therapeutic options in Rhabdomyolysis

Martinez B.

CytoSorb in kidney and liver transplantations – Experiences from Hungary

Fazakas J

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2nd International CytoSorb users meeting shows improved clinical evidence

Berlin. The CytoSorb therapy is safe, easy to handle and able to stabilize the overshooting immune system. These are some of the main results of the second international CytoSorb users meeting, which took place in the first days of October 2015. We thank all 110 participants from 18 countries having joined this platform that enabled users, partners and distributors to exchange their experiences with CytoSorb. Case reports, case series and interim results from several controlled pilot studies were presented and discussed. This was a clear step in CytoSorbents’ continuous strategy to reach a high level of clinical evidence.

Key findings of the symposium include …

 

Key findings of the symposium include:

Safety & Ease of use

  • Treatment has been safe in both critical illnesses and cardiac surgery in more than 8,000 human treatments to date
  • CytoSorb is easy to use without technical complications in a wide range of blood pump systems, including dialysis, continuous renal replacement therapy (CRRT with citrate or heparin anticoagulation) and cardiopulmonary bypass

Early use

Several CytoSorb users showed that the therapy is being used in real-world situations much earlier as an adjunctive therapy to control deadly inflammation and to treat life-threatening illnesses, rather than as a last resort therapy.

Efficiency

  • CytoSorb therapy has contributed to patients’ clinical stability in many ways including:
    • Improving hemodynamic stability
    • Less need for vasopressors
    • Improving metabolic parameters
  • Treatments in liver failure patients have confirmed previous reports of equivalent or superior removal of hepatic toxins from blood, compared with existing liver dialysis therapies. This might be a major new potential in the treatment of viral hepatitis, alcoholic liver disease and others.

Broad indication range

  • CytoSorb has already been applied successfully in a broad range of serious conditions such as severe sepsis, SIRS, septic shock, trauma, rhabdomyolysis, pancreatitis, lung injury, liver and kidney transplantation, liver failure, influenza, cardiac surgery, post-operative inflammation, toxic shock syndrome and many others (e.g. tropical diseases such as Dengue Fever and Scrub Typhus)
  • Preliminary results from two completed cardiac surgery randomized controlled pilot studies from University of Hamburg-Eppendorf and Medical University of Vienna, where CytoSorb was used intra-operatively in a heart-lung machine bypass circuit, as well as data from 142 cardiac surgery patients at University of Cologne, demonstrate:
    • Therapy was well-tolerated and safe without device-related issues, including no heparin removal, no bleeding or coagulation issues, no device set-up concerns
    • Preliminary initial cytokine data show that some cytokines were removed in CytoSorb treated patients compared to control, but overall inflammation in these shorter, lower risk surgeries, was not very high
    • Now that safety has been determined, all three trial sites are interested in extending their treatment experience to complex cardiac surgery, where the risk of inflammation and related complications is much higher
    • These clinical data on safety, ease of use, and feasibility are expected to increase the confidence of the cardiac surgery community to treat a wide range of open heart surgery patients in need with CytoSorb

Presentations

Use of CytoSorb in patients with myoglobinemia

Claus Krenn, Vienna, Austria

Experience with the application of Cytosorb in patients with myoglobinemia.

The immune system and its inflammatory response types

Herwig Gerlach, Berlin, Germany

A comprehensive overview on the mechanisms of the body’s host response, current concepts of the SIRS-MARS-CARS continuum and potential therapeutic avenues to interfere with the disturbed systemic inflammatory response

Cytokin-Adsorption in der Sepsis (in german)

Detlef Kindgen-Milles, Duesseldorf, Germany

A detailed summary on the epidemiology and pathophysiology of sepsis, the rationale for cytokine elimination, conventional techniques and non-specific adsorption approaches with focus on the CytoSorb technology

Levels of immunosuppressive drugs during CytoSorb treatment - In-vitro Study

Steffen Mitzner, Rostock, Germany

Experimental protocol details and first preliminary results on the planned in-vitro study investigating the impact of CytoSorb on drug levels

The impact of CytoSorb on the immune response

John Kellum, Pittsburgh, USA

Most recent evidence on the association between different patterns of cytokines and outcome, CytoSorb’s underlying operating principle and future perspectives for the technology.

The International CytoSorb Registry - Current status

Frank Brunkhorst, Jena, Germany

Overview on the objectives, methods and status of the currently implemented international CytoSorb registry.

Case series of CytoSorb treatments in patients with severe sepsis

Tommaso Laddomada, Zingonia, Italy

Experience using CytoSorb in patients with severe sepsis, septic shock, acute liver failure and rhabdomyolysis

Early application of CytoSorb in septic shock - A 10 vs 10 pilot study

Zsolt Molnar, Szeged, Hungary

Interim analysis results of the first 10 patients included into the ACESS trial.

CytoSorb use in a case of liver failure

Christian Siebers, Munich, Germany

CytoSorb Therapy in a case of sepsis-associated liver dysfunction.

Poster: Role of CytoSorb in optimization of vasopressors and reduction of sepsis scores: A case series

Reshma Tewari, Gurgaon, India

Case series where CytoSorb was successfully used in 10 patients with septic shock

Case series in post-operative cardiac surgery patients

Karl Träger, Ulm, Germany

Interim analysis results on 16 patients treated with CytoSorb for post cardiopulmonary bypass SIRS.

CytoSorb in cardiac surgery with cardiopulmonary bypass (CPB) - A 300 patient three-arm-study

Carolyn Weber, Cologne, Germany

Preliminary interim results of a prospective pilot study using CytoSorb in patients undergoing elective coronary artery bypass grafting (CABG)

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CytoSorbents Reports on Successful 3rd International CytoSorb® Users Meeting

March 22, 2016

Continued Flow of Data Correlating Positive Clinical Improvements with CytoSorb® Usage

BRUSSELS, BELGIUM, March 16, 2016 – CytoSorbents Corporation (NASDAQ: CTSO), a leader in critical care immunotherapy commercializing its CytoSorb® blood filtration technology to reduce deadly uncontrolled inflammation in critically-ill and cardiac surgery patients around the world, announced the conclusion of its successful 3rd International CytoSorb Users Meeting in Brussels, Belgium. Held one day ahead of the International Symposium of Intensive Care and Emergency Medicine (ISICEM), one of the largest international critical care conferences, the Users Meeting brought together 107 members of the CytoSorb® community from a total of 23 countries, to share data from many new pre-clinical and clinical studies. To date, more than 10,000 CytoSorb® treatments have been performed in thousands of patients.

Proceedings 3rd International CytoSorb Users Meeting

proceedings

Some of the most important findings include:

  • In addition to cytokines, CytoSorb® has been shown to remove a broad range of other inflammatory mediators called pathogen (PAMPs) and damage (DAMPs) associated molecular patterns, which play an important role in inducing systemic inflammation in a wide range of critical illnesses. PAMPs are toxins produced or released by bacteria, viruses and fungi that can cause tissue injury or inflammation. DAMPs originate from damaged or necrotic tissue, like HMGB-1, S100 protein, procalcitonin, and activated complement, and are also toxic in excessive quantities. DAMPs and PAMPs are a leading focus of international research on the uncontrolled systemic inflammatory response syndrome
  • The intra-operative application of CytoSorb® in an ongoing three-arm randomized controlled open heart surgery study in Cologne, Germany was associated with a statistically significant decrease in sternal wound infections, a major complication of cardiac surgery with a total of 165 patients enrolled to date
  • In a cardiac surgery evaluation performed at Angers, France, CytoSorb® was used intra-operatively on 10 patients undergoing a diverse set of complex cardiac surgery procedures, similar to patients in the U.S. REFRESH I trial. All ten patients did well, with CytoSorb® credited with helping to stabilize two hemodynamically unstable patients going into extensive and complicated surgery, and reducing the need for vasopressors and extensive, costly, and risky extracorporeal life support that would normally be required in the post-operative period in these patients
  • Four different independent septic shock case series totaling more than 50 treated patients with severe or refractory shock, have all reported a consistent stabilization of the cardiovascular system following treatment, with a reduction in vasopressor support
  • Several studies have suggested that early intervention with aggressive treatment is superior to late intervention in terms of clinical outcomes
  • New systematic data, confirming previous observations, that CytoSorb® can effectively remove liver toxins such as bilirubin, in some cases better than established liver support therapies
  • All of the presenters once again reiterated the safety of the device in all reported applications
  • An update on the start of the PACIFICA trial, using CytoSorb to treat severe acute pancreatitis
  • Reiteration that CytoSorb® is a useful therapy to reduce extensive myoglobinemia that occurs due to rhabdomyolysis due to trauma, burns, or infection

Dr. Phillip Chan, Chief Executive Officer, stated,

“We are pleased to report this initial summary of the 3rd International CytoSorb® Users Meeting. The purpose of these meetings is to disseminate the lessons learned from experienced users so that we can ensure uniformity of treatment and that all users worldwide benefit from the latest information. Although there is always more to learn, we are pleased to see that when CytoSorb® is used in the right way, users continue to experience positive results with the treatment. As we have done in the past, a more detailed report of this meeting will be published in a proceedings booklet that will be available at our CytoSorb website.”

 

Proceedings 3rd International CytoSorb® Users Meeting

proceedings

Presentations

Introduction to the CytoSorb Therapy

John Kellum, Pittsburgh, USA

A comprehensive introduction on blood purification in general and on the CytoSorb therapy in particular, the underlying operating principle derived from preclinical data and its potential benefit in fighting life-threatening infections.

Early cytokine adsorption in septic shock: The ACCES trial

Zsolt Molnar, Szeged, Hungary

Overview on the evolution from a localized insult to life-threatening organ dysfunction caused by dysregulated host response, main conclusions from current CytoSorb evidence and data gained so far for the ACESS trial (Adsorbtion of Cytokines Early in Septic Shock)

Outcome observations in early vs late use in septic shock patients

M Drüner, Emden, Germany

Description of the clinical effects of CytoSorb therapy in septic shock and presentation of outcome observations in early vs. late use.

In Vitro Adsorption of a Broad Spectrum of Sepsis Inflammatory Mediators with CytoSorb

M Gruda, New Jersey, USA

Presentation of brand new in vitro data on the broad-spectrum removal capability of inflammatory mediators including PAMPS and DAMPS by CytoSorb

Quantification and kinetics of bilirubin removal with CytoSorb

S Faenza, Bologna, Italy

Presentation of in vitro results on bilirubin removal and clinical experience with CytoSorb in patients with liver transplantation and liver insufficiency.

Role of CytoSorb in the therapy of severe acute pancreatitis

A Faltlhauser, Weiden, Germany

Presentation of three cases of acute severe pancreatitis treated with CytoSorb and introduction of the upcoming PACIFIC trial investigating CytoSorb in these patients in a controlled fashion.

Treatment support of rhabdomyolysis patients by CytoSorb

D Fries, Innsbruck, Austria

Experience with CytoSorb in patients with severe myoglobinemia due to rhabdomyolysis.

Treatment experience with CytoSorb in severely burnt patients

C Calin, Bucharest, Romania

Experience with CytoSorb in three severely burnt patients after a fireworks accident at a Bucharest nightclub.

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