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Evaluating a CytoSorb Score in Septic Shock (ECSISS)

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ClinicalTrials.gov Identifier: NCT03977688
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborators:
Kantonsspital Münsterlingen
Universitätsklinikum Hamburg-Eppendorf
Kantonsspital Baden
Information provided by (Responsible Party):
Klaus Kogelmann, Klinikum Emden

Brief Summary:

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

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Retrospective
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
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Group/Cohort Intervention/treatment
none Cyto
septic shock, refractory, without Cytokin-adsorption therapy
cyto
septic shock, refractory, treated with Cytokin-adsorption therapy
Device: Cytokin Adsorption
Haemadsorption with Cytokin Adsorber (Cytosorb)




Primary Outcome Measures :
  1. Hospital mortality [ Time Frame: through study completion, an average of 49 days ]

Secondary Outcome Measures :
  1. Icu mortality [ Time Frame: through study completion, an average of 49 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
each patient eligible with icu treated refractory septic shock in the last 4 years
Criteria

Inclusion Criteria:

  • septic shock according Sepsis 3 criteria

Exclusion Criteria:

  • no data available, no icu treatment

Information from the National Library of Medicine

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


Contacts
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Contact: Klaus Kogelmann, MD 00494921983508 k.kogelmann@klinikum-emden.de
Contact: Matthias Drüner 00494921983764 m.druener@klinikum-emden.de

Locations
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Germany
Klinikum Emden Recruiting
Emden, Lower Saxony, Germany, 26721
Contact: Klaus Kogelmann, MD    00494921983508    k.kogelmann@klinikum-emden.de   
Contact: Matthias Drüner    00494921983764    m.druener@klinikum-emden.de   
Sponsors and Collaborators
Klinikum Emden
Kantonsspital Münsterlingen
Universitätsklinikum Hamburg-Eppendorf
Kantonsspital Baden
Investigators
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Principal Investigator: Klaus Kogelmann, MD head of department

Publications of Results:

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Responsible Party: Klaus Kogelmann, Head of department, Prinipal investigator, Klinikum Emden
ClinicalTrials.gov Identifier: NCT03977688     History of Changes
Other Study ID Numbers: 20194
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klaus Kogelmann, Klinikum Emden:
sepsis
septic shock
cytokin adsorption
Additional relevant MeSH terms:
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Sepsis
Shock, Septic
Shock
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes