Immune Homeostasis in Sepsis and Septic Shock (IMHOTEP)

May 31, 2023 updated by: Thomas Karvunidis, Charles University, Czech Republic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • Česká Republika
      • Pilsen, Česká Republika, Czechia, 330 01
        • Recruiting
        • Medical ICU, 1st Dept. of Internal Medicine, Teaching Hospital in Pilsen
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

sepsis/septic shock according SEPSIS-3 definition

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
sepsis/septic shock
target population
Other: transcriptomics
transcriptomics
Other: flow-cytometry
peripheral blood myeloid cells and lymphocytes flow-cytometry
Other: cytokines
peripheral blood cytokine analysis
non-septic critically ill
demographically-matched control group
Other: transcriptomics
transcriptomics
Other: flow-cytometry
peripheral blood myeloid cells and lymphocytes flow-cytometry
Other: cytokines
peripheral blood cytokine analysis
healthy control
control group
Other: transcriptomics
transcriptomics
Other: flow-cytometry
peripheral blood myeloid cells and lymphocytes flow-cytometry
Other: cytokines
peripheral blood cytokine analysis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic "immune status" panel
Time Frame: 2026 - 2028
Diagnostic tool for immune status assessment
2026 - 2028

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Principal Investigator: Thomas Karvunidis, MD, PhD, Carles University Teaching Hospital and Faculty of Medicine in Pilsen, Pilsen, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 26, 2020

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMHOTEP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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