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NCT04448951 Clinical Trial

Immune Homeostasis in Sepsis and Septic Shock

Sepsis Clinical Trial

— IMHOTEP  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04448951
Other study ID # IMHOTEP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date December 31, 2027

Study information
Verified date May 2023
Source Charles University, Czech Republic
Contact Thomas Karvunidis, MD, Ph.D.
Phone +420 377 103 173
Email karvunidist@fnplzen.cz
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2027
Est. primary completion date August 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Czechia Medical ICU, 1st Dept. of Internal Medicine, Teaching Hospital in Pilsen Pilsen Ceská Republika

Sponsors (1)
Lead Sponsor Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immune response description - flow cytometry Detailed description of immune response analyzed by mean of flow cytometry 2024 - 2026
Primary Immune response description - transcriptomics Detailed description of immune response analyzed by mean of transcriptomic analysis 2024 - 2026
Primary Immune response description - ELISA Detailed description of immune response analyzed by mean of ELISA 2024 - 2026
Secondary Diagnostic "immune status" panel Diagnostic tool for immune status assessment 2026 - 2028
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