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Recruiting NCT04448951

Immune Homeostasis in Sepsis and Septic Shock

— Observational Sepsis Immunologic Paralysis Immunologic Suppression Immune Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcriptomics, flow-cytometry, cytokines.
Who it may be relevant to
Registry conditions: Sepsis, Immunologic Paralysis, Immunologic Suppression, Immune Deficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Other transcriptomics
    transcriptomics
  • Other flow-cytometry
    peripheral blood myeloid cells and lymphocytes flow-cytometry
  • Other cytokines
    peripheral blood cytokine analysis

Primary outcome measures

  • Immune response description - flow cytometry [Time frame: 2024 - 2026]
  • Immune response description - transcriptomics [Time frame: 2024 - 2026]
  • Immune response description - ELISA [Time frame: 2024 - 2026]
Secondary outcome measures (1)
  • Diagnostic "immune status" panel [Time frame: 2026 - 2028]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Czechia · 1 center
  • Medical ICU, 1st Dept. of Internal Medicine, Teaching Hospital in Pilsen — Pilsen

Identifiers

NCT: NCT04448951 · IMHOTEP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗