SepsisICU-FERRONCT06928649
Stratifying Critically Ill Patients for Novel Ferroptosis or Pyroptosis Intervention Strategies
A study testing Blood sampling in people with Sepsis and Trauma Related Injuries, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
In order to better determine which therapy is best for patiënts which present with organ falure during the course of their stay in the intesive care unit (ICU) , one has to determine which underlying mechanism is causing this organ falure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Trauma Related Injuries, Subarachnoid Haemorrhage (SAH)
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Mar 2024to Aug 2026
- Phase
- Interventional
- 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
Who may be able to join
- Admitted to the ICU of UZA
- Critically ill and predicted to be hospitalised in the ICU for > 48 hours (i.e. mostly patients admitted for sepsis, trauma, haemorrhagic shock, neurological catastrophe … which means at risk to develop mono-or multiple organ failure)
- With arterial line in place (for blood sampling)
Who cannot join
- Refusal of consent by patient or closest relative
- Postoperative patients after major surgery in whom prolonged ICU stay is not foreseen (i.e. elective cardiac surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerp
Edegem, 2650
Philippe Jorens, MD, PhD, +32 3 821 / 36 35, inzo@uza.be
About this study
Official title: Innovative Cell Death Diagnostics Allowing Stratifying Critically Ill Patients for Novel Ferroptosis or Pyroptosis Intervention Strategies
In order to better determine which therapy is best for patiënts which present with organ falure during the course of their stay in the intesive care unit (ICU) , one has to determine which underlying mechanism is causing this organ falure. We will determine levels of so called "biomarkers" for ferroptosis (a mechan ism of iron-related cell death) in the peripheral blood and biological fluids of criticaly ill patients admitted to the ICU with a catastrrophy (severe infection, trauma ...) . Why ? If it turns out that this ferroptosis plays a role in the ocurrence of organ failure in the critially ill, this will lead to new therapies in the future as drugs become more and more available which can influene this biochemical "pahway". of iron-relatd death.
- Being tested
- Blood sampling
- Medical subject headings
- Sepsis, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
Also called Urine sampling, Bronchoalveolar lavage sampling, Cerebrospinal fluid sampling
Blood sampling: 3 first days of admision, 2 ml of plasma daily Urine, BALF, CSF sampling: 1 day during 3 first days of admission
| Study group | Role | What they receive |
|---|---|---|
| Critical illness | Experimental | Patient who are admitted to the ICU, with a predicted length of stay > 48 hours. Admission due to sepsis, trauma, haemorrhagic shock, neurological catastrophe Receives: Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with survival after 28 days.
Survival in and after ICU.
Measured: 28 days
Secondary outcomes (2)
Change from baseline concentration of Norepinephrine every day during ICU stay
Measured: 28 days
Change in SOFA score during ICU stay
SOFA score, with a higher score for more severe organ failure
Measured: Change from enrollment to 14 days of ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start13 Mar 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Principal investigator, Philppe Jorens, University Hospital, Antwerp
- Investigators
- Philippe Jorens, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928649
- Sponsor's protocol ID
- EDGE 3060
- Acronym
- ICU-FERRO
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Cell Death Diagnostics Allowing Stratifying Critically Ill Patients for Novel Ferroptosis or Pyroptosis Intervention Strategies
- ClinicalTrials.gov ID
- NCT06928649
- Acronym / sponsor ID
- ICU-FERRO / EDGE 3060
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 15 Apr 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.
In order to better determine which therapy is best for patiënts which present with organ falure during the course of their stay in the intesive care unit (ICU) , one has to determine which underlying mechanism is causing this organ falure. We will determine levels of so called "biomarkers" for ferroptosis (a mechan ism of iron-related cell death) in the peripheral blood and biological fluids of criticaly ill patients admitted to the ICU with a catastrrophy (severe infection, trauma ...) . Why ? If it turns out that this ferroptosis plays a role in the ocurrence of organ failure in the critially ill, this will lead to new therapies in the future as drugs become more and more available which can influene this biochemical "pahway". of iron-relatd death.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical illness | Experimental | Diagnostic Test: Blood samplingPatient who are admitted to the ICU, with a predicted length of stay > 48 hours. Admission due to sepsis, trauma, haemorrhagic shock, neurological catastrophe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to the ICU of UZA
- Critically ill and predicted to be hospitalised in the ICU for > 48 hours (i.e. mostly patients admitted for sepsis, trauma, haemorrhagic shock, neurological catastrophe … which means at risk to develop mono-or multiple organ failure)
- With arterial line in place (for blood sampling)
Key exclusion criteria (2 listed)
- Refusal of consent by patient or closest relative
- Postoperative patients after major surgery in whom prolonged ICU stay is not foreseen (i.e. elective cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingAlso: Urine sampling, Bronchoalveolar lavage sampling, Cerebrospinal fluid samplingBlood sampling: 3 first days of admision, 2 ml of plasma daily Urine, BALF, CSF sampling: 1 day during 3 first days of admission | Diagnostic test | Critical illness |
Primary outcome
Number of patients with survival after 28 days.
Time frame: 28 days
Survival in and after ICU.
2 secondary outcomes
Change from baseline concentration of Norepinephrine every day during ICU stay
Time frame: 28 days
Change in SOFA score during ICU stay
Time frame: Change from enrollment to 14 days of ICU stay
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 15 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
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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.
Philippe Jorens, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Sepsis and Trauma Related Injuries, run by University Hospital, Antwerp at 1 site in Belgium.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Apr 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 Belgium. 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 Tom Stroobants, MD (+32 3 821 / 24 52, tom.stroobants@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with survival after 28 days. (time frame: 28 days). 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 15 Apr 2025.