Evaluating a CytoSorb Score in Septic Shock

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.

Conditions

• Severe Sepsis With Septic Shock

Interventions

DEVICE

Cytokin Adsorption

Haemadsorption with Cytokin Adsorber (Cytosorb)

Sponsors & Collaborators

• Kantonsspital Münsterlingen

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• Kantonsspital Baden

  collaborator OTHER

• Klinikum Emden

  lead OTHER

Principal Investigators

• Klaus Kogelmann, MD · head of department

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2019-05-30

Completion

2019-12-30

Countries

• Germany

Study Locations