Actively Recruiting
Immune Homeostasis in Patients With Sepsis and Septic Shock: a Single Center Observational Study
Led by Charles University, Czech Republic · Updated on 2024-08-21
200
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the immune response and its changes in patients with sepsis and septic shock using advanced techniques like transcriptomics, flow cytometry, and cytokine analysis. This observational study aims to describe immune system behavior in these critical conditions and compare it with non-septic critically ill patients and healthy controls. The study involves three participant groups: those with sepsis or septic shock, a demographically matched group of critically ill patients without sepsis, and healthy volunteers. Researchers will collect blood samples to analyze immune cells and cytokines using flow cytometry, transcriptomics, and ELISA methods. The main assessments will take place between 2024 and 2026, with additional diagnostic immune status panels conducted between 2026 and 2028. Participants will be monitored through blood analyses to evaluate immune system changes over time. The study tracks detailed immune responses to better understand sepsis and septic shock. The total participation duration extends with follow-up evaluations for immune status panels through 2028. This study is conducted by Charles University, Czech Republic, and includes adult participants aged 18 and older who provide consent within 24 hours of septic shock diagnosis.
CONDITIONS
Brief Title
Immune Homeostasis in Sepsis and Septic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with sepsis or septic shock (SEPSIS-3 criteria)
- Age 18 years or older
- Able to provide informed consent
- Enrollment within 24 hours after septic shock diagnosis
You will not qualify if you...
- Patient or legal representative does not agree to participate
- Presence of primary or secondary immunodeficiency
- Active blood-related (haematological) cancer
- Active non-blood-related (non-haematological) cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 24 hours after septic shock diagnosis
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - From enrollment through 2026
Participants are observed with blood samples taken for immune response analysis including flow cytometry, transcriptomics, and cytokine analysis.
Periodic blood sample collections during hospitalization and follow-up
Duration - 2026 to 2028
Participants may be monitored for diagnostic immune status panels during long-term follow-up.
Follow-up visits as scheduled for immune status assessment
Trial Site Locations
Total: 1 location
1
Medical ICU, 1st Dept. of Internal Medicine, Teaching Hospital in Pilsen
Pilsen, Česká Republika, Czechia, 330 01
Actively Recruiting
Research Team
T
Thomas Karvunidis, MD, Ph.D.
M
Marcela Královcová, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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