NCT06820905

Brief Summary

Analysing trajectory of critically ill patients with signs of hyperinflammation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,962

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

February 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 6, 2025

Last Update Submit

February 6, 2025

Conditions

Critical IllnessSepsisHyperferritinemiaHyperinflammatory Syndrome

Keywords

criticall illnesssepsisferritinhyperinflammatory syndromesepsis phenotype

Outcome Measures

Primary Outcomes (1)

  • hyperferritinemia

    trajectory of critically ill patients with significant hyperferritinemia and with regard to its dynamics; ferritin value cutt-off

    2025

Secondary Outcomes (4)

  • etiology and association of hyperferritinemia

    2025

  • mortality a morbidity

    2025

  • treatment strategy

    2025

  • stratification

    2025

Study Arms (1)

critically ill patients

critically ill patients admitted to ICU between 01.01.2020 and 31.12.2024

Eligibility Criteria

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

critically ill patients; mix-cases medical ICU population

You may qualify if:

  • critically ill patients
  • admission between 01.01.2020 and 31.12.2024 (5yrs)

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine and Teaching Hospital, Charles University

Pilsen, Czech Republic, 30460, Czechia

Location

MeSH Terms

Conditions

Critical IllnessSepsisHyperferritinemia

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammationIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Thomas Karvunidis, MD, PhD

    Faculty of Medicine and Teaching Hospital, Charles University, Pilsen, Czech Republic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Karvunidis, MD, PhD

CONTACT

+420776160620karvunidist@fnplzen.cz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 11, 2025

Study Start

February 20, 2025

Primary Completion

June 30, 2025

Study Completion

November 30, 2025

Last Updated

February 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR

Locations

CZ(1)