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Immune Homeostasis in Sepsis and Septic Shock

Immune Homeostasis in Patients With Sepsis and Septic Shock: a Single Center Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04448951
Acronym
IMHOTEP
Enrollment
200
Registered
2020-06-26
Start date
2020-09-01
Completion date
2027-12-31
Last updated
2024-08-21

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

Conditions

Sepsis, Immunologic Paralysis, Immunologic Suppression, Immune Deficiency

Keywords

sepsis, septic shock, immune response, immunoparalysis, transcriptomics, flow-cytometry, immunomodulation

Brief summary

Detailed description of immune response and its dynamics in sepsis and septic shock patiens by means of transcriptomics, flow-cytometry and cytokine analysis.

Interventions

transcriptomics

OTHERflow-cytometry

peripheral blood myeloid cells and lymphocytes flow-cytometry

OTHERcytokines

peripheral blood cytokine analysis

Sponsors

Charles University, Czech Republic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* sepsis/septic shock (SEPSIS-3) * age ≥18 * informed consent * inclusion within first 24hrs after development/diagnosis of septic shock

Exclusion criteria

* disagreement of the patient or legal representative with the entry into the study * patients with primary or secondary immunodeficiency * presence of active haematological malignancy or an active non-haematological malignancy

Design outcomes

Primary

MeasureTime frameDescription
Immune response description - flow cytometry2024 - 2026Detailed description of immune response analyzed by mean of flow cytometry
Immune response description - transcriptomics2024 - 2026Detailed description of immune response analyzed by mean of transcriptomic analysis
Immune response description - ELISA2024 - 2026Detailed description of immune response analyzed by mean of ELISA

Secondary

MeasureTime frameDescription
Diagnostic immune status panel2026 - 2028Diagnostic tool for immune status assessment

Countries

Czechia

Contacts

Primary ContactThomas Karvunidis, MD, Ph.D.
karvunidist@fnplzen.cz+420 377 103 173
Backup ContactMarcela Královcová, MD
kralovcovam@fnplzen.cz+420 377 103 173

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026