NCT04448951

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Sep 2020Dec 2027

First Submitted

Initial submission to the registry

June 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

5 years

First QC Date

June 23, 2020

Last Update Submit

August 20, 2024

Conditions

SepsisImmunologic ParalysisImmunologic SuppressionImmune Deficiency

Keywords

sepsisseptic shockimmune responseimmunoparalysistranscriptomicsflow-cytometryimmunomodulation

Outcome Measures

Primary Outcomes (3)

  • Immune response description - flow cytometry

    Detailed description of immune response analyzed by mean of flow cytometry

    2024 - 2026

  • Immune response description - transcriptomics

    Detailed description of immune response analyzed by mean of transcriptomic analysis

    2024 - 2026

  • Immune response description - ELISA

    Detailed description of immune response analyzed by mean of ELISA

    2024 - 2026

Secondary Outcomes (1)

  • Diagnostic "immune status" panel

    2026 - 2028

Study Arms (3)

sepsis/septic shock

target population

Other: transcriptomicsOther: flow-cytometryOther: cytokines

non-septic critically ill

demographically-matched control group

Other: transcriptomicsOther: flow-cytometryOther: cytokines

healthy control

control group

Other: transcriptomicsOther: flow-cytometryOther: cytokines

Interventions

transcriptomicsOTHER

transcriptomics

healthy controlnon-septic critically illsepsis/septic shock
flow-cytometryOTHER

peripheral blood myeloid cells and lymphocytes flow-cytometry

healthy controlnon-septic critically illsepsis/septic shock
cytokinesOTHER

peripheral blood cytokine analysis

healthy controlnon-septic critically illsepsis/septic shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

sepsis/septic shock according SEPSIS-3 definition

You may qualify if:

  • sepsis/septic shock (SEPSIS-3)
  • age ≥18
  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pilsen, Česká Republika, 330 01, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

SepsisImmunologic Deficiency SyndromesShock, Septic

Interventions

Gene Expression ProfilingFlow CytometryCytokines

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsImmune System DiseasesShock

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Thomas Karvunidis, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Karvunidis, MD, Ph.D.

CONTACT

+420 377 103 173karvunidist@fnplzen.cz

Marcela Královcová, MD

CONTACT

+420 377 103 173kralovcovam@fnplzen.cz

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 26, 2020

Study Start

September 1, 2020

Primary Completion

August 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations

CZ(1)