Immune Homeostasis in Sepsis and Septic Shock

NCT04448951 — Recruiting, 200 participants, Charles University, Czech Republic

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

RegistryNCT04448951, acronym IMHOTEP
StatusRecruiting
Study typeObservational
Enrollment200 (Estimated)
SponsorCharles University, Czech Republic (Other)
ConditionsSepsis, Immunologic Paralysis, Immunologic Suppression, Immune Deficiency
Interventionstranscriptomics, flow-cytometry, cytokines (Other)
Datesstart 2020-09-01, primary completion 2025-08-31 (estimated), completion 2027-12-31 (estimated), first posted 2020-06-26, last updated 2024-08-21
Locations1 site in Czechia

Related Papers Related Patents Related Grants Related Experts
All trials for Sepsis All trials for Immunologic Paralysis All trials of transcriptomics All trials of flow-cytometry

-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
sepsis/septic shockOther: transcriptomics; Other: flow-cytometry; Other: cytokinestarget population
non-septic critically illOther: transcriptomics; Other: flow-cytometry; Other: cytokinesdemographically-matched control group
healthy controlOther: transcriptomics; Other: flow-cytometry; Other: cytokinescontrol group
  • transcriptomics (Other): transcriptomics
  • flow-cytometry (Other): peripheral blood myeloid cells and lymphocytes flow-cytometry
  • cytokines (Other): peripheral blood cytokine analysis

+Outcome measures

Primary outcomes

  • Immune response description - flow cytometry [2024 - 2026]: Detailed description of immune response analyzed by mean of flow cytometry
  • Immune response description - transcriptomics [2024 - 2026]: Detailed description of immune response analyzed by mean of transcriptomic analysis
  • Immune response description - ELISA [2024 - 2026]: Detailed description of immune response analyzed by mean of ELISA

Secondary outcomes

  • Diagnostic "immune status" panel [2026 - 2028]: Diagnostic tool for immune status assessment

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Medical ICU, 1st Dept. of Internal Medicine, Teaching Hospital in PilsenPilsen, Česká RepublikaCzechiaRecruiting

+Investigators

  • Thomas Karvunidis, MD, PhD, Principal investigator, Carles University Teaching Hospital and Faculty of Medicine in Pilsen, Pilsen, Czech Republic