SepsisIMHOTEPNCT04448951
Immune Homeostasis in Sepsis and Septic Shock
An observational study of Sepsis and Immunologic Paralysis, run by Charles University, Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Immunologic Paralysis, Immunologic Suppression
- What is being tested?
- transcriptomics, flow-cytometry and cytokines
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2020to 31 Dec 2027
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: sepsis/septic shock according SEPSIS-3 definition
Who may be able to join
- sepsis/septic shock (SEPSIS-3)
- age ≥18
- informed consent
- inclusion within first 24hrs after development/diagnosis of septic shock
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Medical ICU, 1st Dept. of Internal Medicine, Teaching Hospital in Pilsen
Pilsen, Česká Republika, 330 01
Thomas Karvunidis, MD, Ph.D., +420 377 103 173, karvunidist@fnplzen.cz
Marcela Kralovcova, MD, +420 377 103 173, kralovcovam@fnplzen.cz
About this study
Official title: Immune Homeostasis in Patients With Sepsis and Septic Shock: a Single Center Observational Study
Detailed description of immune response and its dynamics in sepsis and septic shock patiens by means of transcriptomics, flow-cytometry and cytokine analysis.
- Being tested
- transcriptomics, flow-cytometry, cytokines
- Keywords
- sepsis, septic shock, immune response, immunoparalysis, transcriptomics, flow-cytometry, immunomodulation
- Medical subject headings
- Sepsis, Immunologic Deficiency Syndromes, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcriptomicsOther
transcriptomics
flow-cytometryOther
peripheral blood myeloid cells and lymphocytes flow-cytometry
cytokinesOther
peripheral blood cytokine analysis
| Study group | Role | What they receive |
|---|---|---|
| sepsis/septic shock | target population Receives: Other: transcriptomics; Other: flow-cytometry; Other: cytokines | |
| non-septic critically ill | demographically-matched control group Receives: Other: transcriptomics; Other: flow-cytometry; Other: cytokines | |
| healthy control | control group Receives: Other: transcriptomics; Other: flow-cytometry; Other: cytokines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response description - flow cytometry
Detailed description of immune response analyzed by mean of flow cytometry
Measured: 2024 - 2026
Immune response description - transcriptomics
Detailed description of immune response analyzed by mean of transcriptomic analysis
Measured: 2024 - 2026
Immune response description - ELISA
Detailed description of immune response analyzed by mean of ELISA
Measured: 2024 - 2026
Secondary outcomes (1)
Diagnostic "immune status" panel
Diagnostic tool for immune status assessment
Measured: 2026 - 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start1 Sep 2020
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Karvunidis, Charles University, Czech Republic
- Investigators
- Thomas Karvunidis, MD, PhD, Principal investigator, Carles University Teaching Hospital and Faculty of Medicine in Pilsen, Pilsen, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448951
- Sponsor's protocol ID
- IMHOTEP
- Acronym
- IMHOTEP
- Status last verified
- Aug 2024
- First submitted
- 23 Jun 2020
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Homeostasis in Patients With Sepsis and Septic Shock: a Single Center Observational Study
- ClinicalTrials.gov ID
- NCT04448951
- Acronym / sponsor ID
- IMHOTEP / IMHOTEP
- Keywords
- sepsis, septic shock, immune response, immunoparalysis, transcriptomics, flow-cytometry, immunomodulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Detailed description of immune response and its dynamics in sepsis and septic shock patiens by means of transcriptomics, flow-cytometry and cytokine analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sepsis/septic shock | – | Other: transcriptomics, Other: flow-cytometry, Other: cytokinestarget population |
| non-septic critically ill | – | Other: transcriptomics, Other: flow-cytometry, Other: cytokinesdemographically-matched control group |
| healthy control | – | Other: transcriptomics, Other: flow-cytometry, Other: cytokinescontrol group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- sepsis/septic shock according SEPSIS-3 definition
Key inclusion criteria (4 listed)
- sepsis/septic shock (SEPSIS-3)
- age ≥18
- informed consent
- inclusion within first 24hrs after development/diagnosis of septic shock
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcriptomicstranscriptomics | Other | healthy control, non-septic critically ill, sepsis/septic shock |
| flow-cytometryperipheral blood myeloid cells and lymphocytes flow-cytometry | Other | healthy control, non-septic critically ill, sepsis/septic shock |
| cytokinesperipheral blood cytokine analysis | Other | healthy control, non-septic critically ill, sepsis/septic shock |
Primary outcome
Immune response description - flow cytometry
Time frame: 2024 - 2026
Detailed description of immune response analyzed by mean of flow cytometry
Immune response description - transcriptomics
Time frame: 2024 - 2026
Detailed description of immune response analyzed by mean of transcriptomic analysis
Immune response description - ELISA
Time frame: 2024 - 2026
Detailed description of immune response analyzed by mean of ELISA
1 secondary outcome
Diagnostic "immune status" panel
Time frame: 2026 - 2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Karvunidis, MD, PhD principal investigator
Carles University Teaching Hospital and Faculty of Medicine in Pilsen, Pilsen, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Immunologic Paralysis, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Karvunidis, MD, Ph.D. (+420 377 103 173, karvunidist@fnplzen.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response description - flow cytometry (time frame: 2024 - 2026). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.