Critical IllnessHYFERNCT06820905
Hyperinflammation and Hyperferritinemia in Critically Ill Patients
An observational study of Critical Illness and Sepsis, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Analysing trajectory of critically ill patients with signs of hyperinflammation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Sepsis, Hyperferritinemia
- How many people
- 1,962 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Feb 2025to 30 Nov 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: critically ill patients; mix-cases medical ICU population
Who may be able to join
- critically ill patients
- admission between 01.01.2020 and 31.12.2024 (5yrs)
Who cannot join
- none
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
Faculty of Medicine and Teaching Hospital, Charles University
Pilsen, Czech Republic, 30460
About this study
Official title: Hyperinflammation and Hyperferritinemia in Critically Ill Patients: a Retrospective Observational Single-center Analysis
Analysing trajectory of critically ill patients with signs of hyperinflammation
- Keywords
- criticall illness, sepsis, ferritin, hyperinflammatory syndrome, sepsis phenotype
- Medical subject headings
- Critical Illness, Sepsis, Hyperferritinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| critically ill patients | critically ill patients admitted to ICU between 01.01.2020 and 31.12.2024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
hyperferritinemia
trajectory of critically ill patients with significant hyperferritinemia and with regard to its dynamics; ferritin value cutt-off
Measured: 2025
Secondary outcomes (4)
etiology and association of hyperferritinemia
etiology and association of hyperferritinemia with infectioius a non-infectious diseases/conditions
Measured: 2025
mortality a morbidity
mortality a morbidity of patients with significant hyperferritinemia
Measured: 2025
treatment strategy
association of hyperferritinemia and treatment strategy
Measured: 2025
stratification
patient stratification according to hyperferritinemia/hyperinflammation
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,962 participants (estimated)
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, Faculty of Medicine and Teaching Hospital, Charles University, Pilsen, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820905
- Sponsor's protocol ID
- HYFER_2025
- Acronym
- HYFER
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperinflammation and Hyperferritinemia in Critically Ill Patients: a Retrospective Observational Single-center Analysis
- ClinicalTrials.gov ID
- NCT06820905
- Acronym / sponsor ID
- HYFER / HYFER_2025
- Keywords
- criticall illness, sepsis, ferritin, hyperinflammatory syndrome, sepsis phenotype
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,962 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 11 Feb 2025 (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.
Analysing trajectory of critically ill patients with signs of hyperinflammation
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critically ill patients | – | –critically ill patients admitted to ICU between 01.01.2020 and 31.12.2024 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patients; mix-cases medical ICU population
Key inclusion criteria (2 listed)
- critically ill patients
- admission between 01.01.2020 and 31.12.2024 (5yrs)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hyperferritinemia
Time frame: 2025
trajectory of critically ill patients with significant hyperferritinemia and with regard to its dynamics; ferritin value cutt-off
4 secondary outcomes
etiology and association of hyperferritinemia
Time frame: 2025
mortality a morbidity
Time frame: 2025
treatment strategy
Time frame: 2025
stratification
Time frame: 2025
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 11 Feb 2025.
- Individual participant dataSharing planned: Yes
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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
Faculty of Medicine and Teaching Hospital, Charles University, 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 Critical Illness and Sepsis, 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Feb 2025. 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, PhD (+420776160620, karvunidist@fnplzen.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hyperferritinemia (time frame: 2025). 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 11 Feb 2025.