Evaluating a CytoSorb Score in Septic Shock (ECSISS)
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|ClinicalTrials.gov Identifier: NCT03977688|
Recruitment Status : Completed
First Posted : June 6, 2019
Last Update Posted : February 19, 2020
Systemic hyperinflammatory states, e.g. triggered by infection/sepsis, represent a major challenge for modern medicine. After an initially localized onset, inflammation can extend to an excessive, uncontrolled inflammatory reaction affecting the entire body and can trigger circulatory failure with subsequent irreversible multiple organ failure. Despite all the medical advances made in recent years, sepsis continues to be a substantial problem, as almost all therapeutic approaches have failed to prove their efficacy to date. Mortality in this clinical entity thus remains extremely high. In Germany alone, more than 100,000 people suffer from sepsis or septic shock every year, nearly half of whom die despite optimal therapy. Thus, sepsis is the third most common cause of death, has major importance both from a medical but also from an economical viewpoint, and approaches that could contribute to its successful treatment need to be further developed and explored.
If a patient experiences the spread of bacteria or their constituents in the blood stream due to an uncontrolled source of infection, the result is a deliberately triggered physiological defense reaction of the body. In many patients, however, there is a pathological dysregulation of these mechanisms, in a way that the defense reaction goes far beyond the physiological level required, resulting in an excessive immune response of the body, which is mainly facilitated by inflammatory mediators such as cytokines and chemokines. The immune response spreads throughout the body and also dissipates into organs unaffected by the original infection. In cases of such unwanted overshooting immune responses, an attempt to regain control of the described deleterious systemic events seems reasonable by removing the excess amount of cytokines from the blood, thus preventing or treating organ failure.
In this context, current therapeutic approaches increasingly focus on the elimination of inflammatory mediators.
In recent years, hemoadsorption, using a new adsorber (CytoSorb), has been used to treat sepsis and other conditions of hyperinflammation. The advantage of this therapeutic principle is that a wide range of inflammatory mediators are removed. In conjunction with the enormous elimination capacity, the effective and rapid reduction of mediators can be achieved.
To date, there have been more than 61,000 treatments using this procedure worldwide without device-related side effects being reported. The investigators have been treating patients with this procedure for over 5 years with consistently very favorable results. Therefore, the investigators would like to expand and deepen their observations with the proposed project.
|Condition or disease||Intervention/treatment|
|Severe Sepsis With Septic Shock||Device: Cytokin Adsorption|
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||Evaluating a CytoSorb Score in Septic Shock - a Retrospective Multicenter Data Analysis|
|Actual Study Start Date :||March 1, 2019|
|Actual Primary Completion Date :||May 30, 2019|
|Actual Study Completion Date :||December 30, 2019|
septic shock, refractory, without Cytokin-adsorption therapy
septic shock, refractory, treated with Cytokin-adsorption therapy
Device: Cytokin Adsorption
Haemadsorption with Cytokin Adsorber (Cytosorb)
- Hospital mortality [ Time Frame: through study completion, an average of 49 days ]
- Icu mortality [ Time Frame: through study completion, an average of 49 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977688
|Emden, Lower Saxony, Germany, 26721|
|Principal Investigator:||Klaus Kogelmann, MD||head of department|