Public University assesses the effects of CytoSorb Hemoperfusion on the Development on Immunoparalysis

The Radboud University in collaboration with CytoSorbents Europe GmbH is commencing recruitment for the Study on the Effects of the Cytokine-adsorber CytoSorb on the Development of Immunoparalysis in Humans.

The conditions are Sepsis, Immune Deficiency, Hemoperfusion, Blood Purification.

Sepsis is an inflammatory syndrome with high mortality rates and increasing incidence. Sepsis-induced immunoparalysis, increasingly recognized as the overriding immune disorder in sepsis patients, attributes significantly to late mortality in sepsis patients.

The investigators hypothesize that 'blood purification' techniques targeted at the removal of excess circulating cytokines, such as the CytoSorb hemoperfusion device, might prevent or attenuate the development of immunoparalysis.

The objective of this trial is to determine the effects of CytoSorb hemoperfusion on the development of immunoparalysis in a repeated experimental endotoxemia model in healthy male volunteers.

A new clinical trial is recruiting patients in the following locations: Radboud University Medical Center, Nijmegen, Gelderland, Netherlands, 6500HB.

The trial officially began on the September 16, 2020 and is planned to complete on December 31, 2020.

Among the exclusion criteria are:

  • Use of any medication
  • Smoking
  • Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients.
  • History or signs of atopic syndrome (asthma, rhinitis with medication and/or eczema).
  • History or signs of hematological disease

and others.

Radboud University (RU, Radboud Universiteit, formerly Katholieke Universiteit Nijmegen) is a public Roman Catholic university with a strong focus on research located in Nijmegen, the Netherlands. The university bears the name of Saint Radboud, a 9th century Dutch bishop who was known for his intellect and support of the underprivileged.

Established in 1923, Radboud University has consistently been included in the top 150 of universities in the world by four major university ranking tables.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04643639

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