An open-label randomized controlled experimental endotoxemia study on the effects of the cytokine-adsorbing hemofilter CytoSorb on the development of immunoparalysis in humans

An open-label randomized controlled experimental endotoxemia study on the effects of the cytokine-adsorbing hemofilter CytoSorb on the development of immunoparalysis in humans - The EndoSorb study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55310

Enrollment

Registered

2020-07-22

Start date

2020-09-16

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood stream infection immunoparalysis

Interventions

CytoSorb hemoperfusion for six hours

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Written informed consent - Male - Age * 18 and * 35 years - Healthy (as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and routine clinical laboratory parameters)

Exclusion criteria

Exclusion criteria: - Use of any medication - Smoking - Hypersensitivity to any of the (non)investigational products or their excipients - History of: - Any immune-related disorder - Aneurysmal or hemorrhagic disease - Renal or hepatic impairment - Recent infection (

Design outcomes

Primary

Measure	Time frame
Plasma IL-6 levels during the second LPS challenge. Comparison of CytoSorb group with control group. IL-6 is an archetypal pro-inflammatory cytokine with high relevance to sepsis.	—

Secondary

Measure	Time frame
- Plasma levels of other inflammatory cytokines (including, but not limited to IL-6, IL-8, IL-10, MCP-1, CXCL-10, MIP-1, MIP-1, and G-CSF) during the second LPS chal-lenge. - mHLA-DR expression. - Plasma levels of inflammatory cytokines (including, but not limited to IL-6, IL-8, IL-10, MCP-1, CXCL-10, MIP-1, MIP-1, and G-CSF) during the first LPS challenge - Norepinephrine sensitivity during the first LPS challenge. - Cytokine concentrations in afferent and efferent tubing of the CytoSorb filter. Togeth-er with the blood flow, cytokine clearance by the filter can be calculated. - Endotoxemia-induced changes in leukocyte numbers and differential count - Endotoxemia-induced increase in body temperature - Endotoxemia-induced symptoms - Endotoxemia-induced hemodynamic alterations - Endotoxemia-induced increase in markers of endothelial injury (VCAM/ICAM)	—

Measure

Time frame

- Plasma levels of other inflammatory cytokines (including, but not limited to IL-6, IL-8, IL-10, MCP-1, CXCL-10, MIP-1*, MIP-1*, and G-CSF) during the second LPS chal-lenge. - mHLA-DR expression. - Plasma levels of inflammatory cytokines (including, but not limited to IL-6, IL-8, IL-10, MCP-1, CXCL-10, MIP-1*, MIP-1*, and G-CSF) during the first LPS challenge - Norepinephrine sensitivity during the first LPS challenge. - Cytokine concentrations in afferent and efferent tubing of the CytoSorb filter. Togeth-er with the blood flow, cytokine clearance by the filter can be calculated. - Endotoxemia-induced changes in leukocyte numbers and differential count - Endotoxemia-induced increase in body temperature - Endotoxemia-induced symptoms - Endotoxemia-induced hemodynamic alterations - Endotoxemia-induced increase in markers of endothelial injury (VCAM/ICAM)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)