Immune Homeostasis in Sepsis and Septic Shock

Recruiting

• Conditions: Sepsis; Immune Deficiency; Immunologic Paralysis; Immunologic Suppression
• Interventions: Other: transcriptomics; Other: flow-cytometry; Other: cytokines

• Registration Number: NCT04448951
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-26
• Study Start: 2020-09-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-08-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy control	cytokines	control group
sepsis/septic shock	flow-cytometry	target population
sepsis/septic shock	cytokines	target population
non-septic critically ill	transcriptomics	demographically-matched control group
non-septic critically ill	flow-cytometry	demographically-matched control group
non-septic critically ill	cytokines	demographically-matched control group
healthy control	flow-cytometry	control group
healthy control	transcriptomics	control group
sepsis/septic shock	transcriptomics	target population

Primary Outcome Measures

Name	Time	Method
Immune response description - flow cytometry	2024 - 2026	Detailed description of immune response analyzed by mean of flow cytometry
Immune response description - ELISA	2024 - 2026	Detailed description of immune response analyzed by mean of ELISA
Immune response description - transcriptomics	2024 - 2026	Detailed description of immune response analyzed by mean of transcriptomic analysis

Secondary Outcome Measures

Name	Time	Method
Diagnostic "immune status" panel	2026 - 2028	Diagnostic tool for immune status assessment

Trial Locations

Locations (1)

Medical ICU, 1st Dept. of Internal Medicine, Teaching Hospital in Pilsen; 🇨🇿 Pilsen, Česká Republika, Czechia