Myeloid Cells` Immunosuppressive activity in Sepsis

Conditions: A41
A40
Other sepsis
Streptococcal sepsis

Registration Number: DRKS00024838

Lead Sponsor: Klinik für Anästhesiologie - Universitätsklinikum Heidelberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 100

Inclusion Criteria

Patients with Sepsis:
Consent by the legal representative
At least 2 SIRS criteria met:
- temperature <36ºC or> 38ºC
- tachycardia (> 90 /min)
- leukocytosis (> 12,000 /µl) OR leukopenia (<4,000 /µl) OR left shift (>10% immature blasts)
- Tachypnea (> 20 /min) OR paCO2 <32 mmHg OR oxygenation index (FiO2/paO2) <200 OR mechanical Ventilation
Clinical or microbiological evidence of infection
Sepsis-associated organ dysfunction indicated by a change in the Sequential Organ Failure Assessment (SOFA) score by 2 or more points (compared to previous day)

Healthy volunteers:
Informed consent

Exclusion Criteria

Common exclusion criteria of all study groups:
Pregnancy
Inclusion in an interventional study
Infectious viral diseases (HBV, HCV, HIV)
Iatrogenic immunosuppression
Pre-existing autoimmune diseases
Treatment with checkpoint inhibitors

Specific exclusion criteria of patients with sepsis:
Diagnosis sepsis >24 h.

Specific exclusion criteria of healthy volunteers:
One of the following states during the last 7 days:
- Influenza infection or flu
- Sports injuries or other trauma
- Large-scale dental interventions (e.g., tooth extraction)
- Blood or platelet donation.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunophenotyping of immune cell populations by flow cytometric analysis of immune receptors on the cell surface of monocytes, granulocytes, low-density granulocytes and MDSC.

Secondary Outcome Measures

Name	Time	Method
Measurment of the influence of the immune cell populations with immunosuppressor function on T-cell proliferation using stimulation and flow cytometry<br>Measurment of functional competence of the individual subpopulations for cytokine release using stimulation and ELISA<br>Quantification of chemokines, cytokines, metabolites and enzyme activities in plasma and in isolated immune cell populations using ELISA and mass spectrometry<br>Measurement of the metabolic pathways used in isolated immune cell populations using Seahorse™ technology<br>Measurement of gene expression, in particular with regard to changes in factors relevant for immunosuppressive functions using qPCR<br>Occurrence of secondary infections<br>28-day survival<br>Length of stay in hospital and intensive care unit