RecruitingNCT04448951IMHOTEPUpdated Aug 21, 2024

Immune Homeostasis in Sepsis and Septic Shock

An observational study in Sepsis, Immunologic Paralysis and Immunologic Suppression, sponsored by Charles University, Czech Republic. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Charles University, Czech Republic · Observational

From the registry’s dates

Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
Started Sep 2020; still recruiting 6 years 1 month later.

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 200
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Sepsis
Immunologic Paralysis
Immunologic Suppression
Immune Deficiency

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Keywords

sepsis
septic shock
immune response
immunoparalysis
transcriptomics
flow-cytometry
immunomodulation

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 458 are open to participants now.

This study's planned enrollment of 200 is above the median of 160 across 929 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Charles University, Czech Republic is the lead sponsor of 220 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

sepsis/septic shock according SEPSIS-3 definition

Inclusion criteria

sepsis/septic shock (SEPSIS-3)
age ≥18
informed consent
inclusion within first 24hrs after development/diagnosis of septic shock

Exclusion criteria

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

Observational model: Case-control
Time perspective: Prospective
Enrollment: 200 participants (estimated)
Target follow-up: 90 Days
Patient registry: Yes
Biospecimen retention: Samples with dna

Groups and cohorts

sepsis/septic shock
target population
Other: transcriptomics · Other: flow-cytometry · Other: cytokines
non-septic critically ill
demographically-matched control group
Other: transcriptomics · Other: flow-cytometry · Other: cytokines
healthy control
control group
Other: transcriptomics · Other: flow-cytometry · Other: cytokines

Interventions

Othertranscriptomics
transcriptomics
Otherflow-cytometry
peripheral blood myeloid cells and lymphocytes flow-cytometry
Othercytokines
peripheral blood cytokine analysis

What researchers measure

Primary outcomes

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

Secondary outcomes

Diagnostic "immune status" panel
Diagnostic tool for immune status assessment
Time frame: 2026 - 2028

Study locations

1 of 1 sites recruiting

Medical ICU, 1st Dept. of Internal Medicine, Teaching Hospital in Pilsen
Pilsen, Česká Republika 330 01, Czechia
- Thomas Karvunidis, MD, Ph.D. · Contact · karvunidist@fnplzen.cz · +420 377 103 173
- Marcela Kralovcova, MD · Contact · kralovcovam@fnplzen.cz · +420 377 103 173
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04448951
Lead sponsor: Charles University, Czech Republic
Responsible party: Thomas Karvunidis (Principal investigator, Charles University, Czech Republic) — Principal investigator
First posted: Jun 26, 2020
Start date: Sep 1, 2020
Primary completion: Aug 31, 2025 (estimated)
Completion: Dec 31, 2027 (estimated)
Last update: Aug 21, 2024

Study contacts

Thomas Karvunidis, MD, Ph.D.

Contact

karvunidist@fnplzen.cz

+420 377 103 173

Marcela Královcová, MD

Contact

kralovcovam@fnplzen.cz

+420 377 103 173

Thomas Karvunidis, MD, PhD

principal investigator · Carles University Teaching Hospital and Faculty of Medicine in Pilsen, Pilsen, Czech Republic

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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