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NCT Number: NCT04448951

Immune Homeostasis in Sepsis and Septic Shock

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

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Key information

Conditions

Sepsis Immune Deficiency Immune System Diseases Immunologic Deficiency Syndromes Immunologic Paralysis Immunologic Suppression Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcriptomics

Other

transcriptomics

flow-cytometry

Other

peripheral blood myeloid cells and lymphocytes flow-cytometry

cytokines

Other

peripheral blood cytokine analysis

Primary outcomes

  1. Immune response description - flow cytometry

    Time frame: 2024 - 2026

    Detailed description of immune response analyzed by mean of flow cytometry

  2. Immune response description - transcriptomics

    Time frame: 2024 - 2026

    Detailed description of immune response analyzed by mean of transcriptomic analysis

  3. Immune response description - ELISA

    Time frame: 2024 - 2026

    Detailed description of immune response analyzed by mean of ELISA

Secondary outcomes

  1. Diagnostic "immune status" panel

    Time frame: 2026 - 2028

    Diagnostic tool for immune status assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Marcela Královcová, MD

CONTACT

[email protected]

+420 377 103 173

Thomas Karvunidis, MD, Ph.D.

CONTACT

[email protected]

+420 377 103 173

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Acronym: IMHOTEP

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Jun 26, 2020
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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