Immune Homeostasis in Sepsis and Septic Shock

NCT ID: NCT04448951

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Sepsis Immunologic Paralysis Immunologic Suppression Immune Deficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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sepsis/septic shock

target population

transcriptomics

Intervention Type OTHER

transcriptomics

flow-cytometry

Intervention Type OTHER

peripheral blood myeloid cells and lymphocytes flow-cytometry

cytokines

Intervention Type OTHER

peripheral blood cytokine analysis

non-septic critically ill

demographically-matched control group

transcriptomics

Intervention Type OTHER

transcriptomics

flow-cytometry

Intervention Type OTHER

peripheral blood myeloid cells and lymphocytes flow-cytometry

cytokines

Intervention Type OTHER

peripheral blood cytokine analysis

healthy control

control group

transcriptomics

Intervention Type OTHER

transcriptomics

flow-cytometry

Intervention Type OTHER

peripheral blood myeloid cells and lymphocytes flow-cytometry

cytokines

Intervention Type OTHER

peripheral blood cytokine analysis

Interventions

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transcriptomics

transcriptomics

Intervention Type OTHER

flow-cytometry

peripheral blood myeloid cells and lymphocytes flow-cytometry

Intervention Type OTHER

cytokines

peripheral blood cytokine analysis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Thomas Karvunidis

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Karvunidis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Medical ICU, 1st Dept. of Internal Medicine, Teaching Hospital in Pilsen

Pilsen, Česká Republika, Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Thomas Karvunidis, MD, Ph.D.

Role: CONTACT

+420 377 103 173

Marcela Královcová, MD

Role: CONTACT

+420 377 103 173

Facility Contacts

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Thomas Karvunidis, MD, Ph.D.

Role: primary

+420 377 103 173

Marcela Kralovcova, MD

Role: backup

+420 377 103 173

Other Identifiers

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IMHOTEP

Identifier Type: -

Identifier Source: org_study_id

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