Evaluating a CytoSorb Score in Septic Shock

NCT03977688 | Completed

• 1 other identifier: 20194
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Sepsis With Septic Shock

Keywords

sepsis; septic shock; cytokin adsorption

Outcome Measures

Primary Outcomes (1)

• Hospital mortality

  through study completion, an average of 49 days

Secondary Outcomes (1)

• Icu mortality

  through study completion, an average of 49 days

Study Arms (2)

none Cyto

septic shock, refractory, without Cytokin-adsorption therapy

cyto

septic shock, refractory, treated with Cytokin-adsorption therapy

Device: Cytokin Adsorption

Interventions

Cytokin Adsorption DEVICE

Haemadsorption with Cytokin Adsorber (Cytosorb)

cyto

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

each patient eligible with icu treated refractory septic shock in the last 4 years

You may qualify if:

• septic shock according Sepsis 3 criteria

You may not qualify if:

• no data available, no icu treatment

Sponsors & Collaborators

• Klinikum Emden: lead
• Kantonsspital Münsterlingen: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Kantonsspital Baden: collaborator

Study Sites (1)

Klinikum Emden

Emden, Lower Saxony, 26721, Germany

Location

Related Publications (8)

• Fleischmann C, Thomas-Rueddel DO, Hartmann M, Hartog CS, Welte T, Heublein S, Dennler U, Reinhart K. Hospital Incidence and Mortality Rates of Sepsis. Dtsch Arztebl Int. 2016 Mar 11;113(10):159-66. doi: 10.3238/arztebl.2016.0159.

  PMID: 27010950 RESULT

• Seymour CW, Rosengart MR. Septic Shock: Advances in Diagnosis and Treatment. JAMA. 2015 Aug 18;314(7):708-17. doi: 10.1001/jama.2015.7885.

  PMID: 26284722 RESULT

• Iskander KN, Osuchowski MF, Stearns-Kurosawa DJ, Kurosawa S, Stepien D, Valentine C, Remick DG. Sepsis: multiple abnormalities, heterogeneous responses, and evolving understanding. Physiol Rev. 2013 Jul;93(3):1247-88. doi: 10.1152/physrev.00037.2012.

  PMID: 23899564 RESULT

• Poli EC, Rimmele T, Schneider AG. Hemoadsorption with CytoSorb(R). Intensive Care Med. 2019 Feb;45(2):236-239. doi: 10.1007/s00134-018-5464-6. Epub 2018 Nov 16. No abstract available.

  PMID: 30446798 RESULT

• Kogelmann K, Jarczak D, Scheller M, Druner M. Hemoadsorption by CytoSorb in septic patients: a case series. Crit Care. 2017 Mar 27;21(1):74. doi: 10.1186/s13054-017-1662-9.

  PMID: 28343448 RESULT

• Friesecke S, Stecher SS, Gross S, Felix SB, Nierhaus A. Extracorporeal cytokine elimination as rescue therapy in refractory septic shock: a prospective single-center study. J Artif Organs. 2017 Sep;20(3):252-259. doi: 10.1007/s10047-017-0967-4. Epub 2017 Jun 6.

  PMID: 28589286 RESULT

• Ferreira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. doi: 10.1001/jama.286.14.1754.

  PMID: 11594901 RESULT

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 RESULT

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Klaus Kogelmann, MD

  head of department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department, Prinipal investigator

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 6, 2019
• Study Start: March 1, 2019
• Primary Completion: May 30, 2019
• Study Completion: December 30, 2019
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

DE (1)