AnemiaIRON-ICUNCT07781540
Iron Deficiency at ICU Discharge
An observational study of Anemia and Post ICU Syndrome, run by Università degli Studi di Ferrara at 4 sites in 2 countries.
Trial summary
IRON-RECOVERY is a prospective, multicenter, observational cohort study designed to determine the prevalence of iron deficiency at intensive care unit (ICU) discharge and to evaluate its association with post-ICU clinical recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Post ICU Syndrome, Red Blood Cell Transfusions
- What is being tested?
- transferrin saturation
- How many people
- 462 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 29 Jul 2026to 30 Jan 2028
- 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: All critically ill patients alive at ICU discharge
Who may be able to join
- Age ≥18 years
- ICU length of stay ≥72 hours
- Survival to ICU discharge
Who cannot join
- Known hematologic diseases affecting erythropoiesis (e.g., aplastic anemia, myelodysplastic syndromes)
- Pregnancy
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Italy3 sites, 3 recruiting
- Recruiting
Università di Ferrara
Ferrara, Ferrara, 44121
Alberto Fogagnolo, MD, +39 0532537000, alberto.fogagnolo@gmail.com
Savino Spadaro, PhD, savinospadaro@gmail.com
- Not yet recruiting
Policlinico Universitario Agostino Gemelli
Roma, 00168
Giorgia Spinazzola, 06 3015.1, giorgia.spinazzola@policlinicogemelli.it
- Not yet recruiting
Anestesia e Rianimazione Cardio-Toraco-Vascolare
Siena
Federico Franchi, 0577 586819., federico.franchi@unisi.it
Belgium1 site, 1 recruiting
- Not yet recruiting
Hospital Erasme
Brussels
Fabio Silvio Taccone, + 32 (0)2 541 33 87, Fabio.Taccone@ulb.be
About this study
Official title: Iron Deficiency at ICU Discharge and Its Impact on Post-critical Illness Recovery. The IRON-ICU Study
IRON-RECOVERY is a prospective, multicenter, observational cohort study designed to determine the prevalence of iron deficiency at intensive care unit (ICU) discharge and to evaluate its association with post-ICU clinical recovery.
Anemia is highly prevalent in critically ill patients and frequently persists after ICU discharge. Although inflammation-induced iron dysregulation is considered one of the main mechanisms underlying persistent anemia, iron deficiency remains largely under-recognized in this population because conventional biomarkers, particularly ferritin, are influenced by the inflammatory response. Transferrin saturation (TSAT) has emerged as a more reliable marker of iron availability and may better identify patients with iron-restricted erythropoiesis.
Read more
Adult patients admitted to participating ICUs for at least 72 hours will undergo assessment of iron status at ICU discharge using routine laboratory tests, including hemoglobin, serum iron, transferrin, ferritin, TSAT, and inflammatory markers. When available, admission iron parameters will also be collected to evaluate changes during the ICU stay. No study-specific therapeutic intervention will be mandated, and all treatment decisions, including intravenous iron administration, will remain at the discretion of the treating physicians.
The primary objective is to determine the prevalence of iron deficiency (defined as TSAT <20%) at ICU discharge. Secondary objectives include evaluating the association between iron deficiency and post-ICU red blood cell transfusion requirements, hemoglobin recovery, functional status assessed by EQ-5D, hospital readmission, mortality, and days alive and out of hospital. Exploratory analyses will assess the association between intravenous iron therapy and clinical outcomes after adjustment for confounding factors. Also, risk factors for ICU-acquired iron deficiency will be investigated.
The findings of this study are expected to provide the first prospective multicenter estimate of iron deficiency at ICU discharge and to inform the design of future interventional trials evaluating iron replacement as part of post-ICU patient blood management strategies.
- Being tested
- transferrin saturation
- Keywords
- Anemia, Iron deficiencies
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transferrin saturationDiagnostic test
Also called EQ-5D questionnaire
All patients will be tested for absolute or relative iron deficiency
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | All critically ill patients are eligible for the study Receives: Diagnostic Test: transferrin saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron deficiency
iron deficiency will be defined as: TSAT <20%, regardless of ferritin levels and/or Ferritin <100 ng/mL
Measured: The day of ICU discharge (day 1)
Iron deficiency at ICU admission
iron deficiency will be defined as: TSAT <20%, regardless of ferritin levels and/or Ferritin <100 ng/mL
Measured: ICU admission
Secondary outcomes (7)
Proportion of patients receiving RBCT after ICU discharge
Proportion of patients receiving RBCT after ICU discharge
Measured: 30-day
Hemoglobin level 28 days after ICU discharge
Hemoglobin level at hospital discharge and/or 28 days after ICU discharge
Measured: up to 28-days after ICU discharge
Functional recovery
assessed using the EQ-5D questionnaire
Measured: up to 90-day after ICU discharge
Hospital readmission
Percentage of hospital readmission
Measured: up to 180-days after ICU discharge
Mortality
30-day mortality
Measured: 30-day
mortality
90-day mortality
Measured: 90-day
mortality
180-days mortality
Measured: 180-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start29 Jul 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 462 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Fogagnolo, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781540
- Sponsor's protocol ID
- IRON-ICU
- Acronym
- IRON-ICU
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared under reasonable requests
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency at ICU Discharge and Its Impact on Post-critical Illness Recovery. The IRON-ICU Study
- ClinicalTrials.gov ID
- NCT07781540
- Acronym / sponsor ID
- IRON-ICU / IRON-ICU
- Keywords
- Anemia, Iron deficiencies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 462 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 24 Aug 2026 (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.
IRON-RECOVERY is a prospective, multicenter, observational cohort study designed to determine the prevalence of iron deficiency at intensive care unit (ICU) discharge and to evaluate its association with post-ICU clinical recovery.
Anemia is highly prevalent in critically ill patients and frequently persists after ICU discharge. Although inflammation-induced iron dysregulation is considered one of the main mechanisms underlying persistent anemia, iron deficiency remains largely under-recognized in this population because conventional biomarkers, particularly ferritin, are influenced by the inflammatory response. Transferrin saturation (TSAT) has emerged as a more reliable marker of iron availability and may better identify patients with iron-restricted erythropoiesis.
Adult patients admitted to participating ICUs for at least 72 hours will undergo assessment of iron status at ICU discharge using routine laboratory tests, including hemoglobin, serum iron, transferrin, ferritin, TSAT, and inflammatory markers. When available, admission iron parameters will also be collected to evaluate changes during the ICU stay. No study-specific therapeutic intervention will be mandated, and all treatment decisions, including intravenous iron administration, will remain at the discretion of the treating physicians.
The primary objective is to determine the prevalence of iron deficiency (defined as TSAT <20%) at ICU discharge. Secondary objectives include evaluating the association between iron deficiency and post-ICU red blood cell transfusion requirements, hemoglobin recovery, functional status assessed by EQ-5D, hospital readmission, mortality, and days alive and out of hospital. Exploratory analyses will assess the association between intravenous iron therapy and clinical outcomes after adjustment for confounding factors. Also, risk factors for ICU-acquired iron deficiency will be investigated.
The findings of this study are expected to provide the first prospective multicenter estimate of iron deficiency at ICU discharge and to inform the design of future interventional trials evaluating iron replacement as part of post-ICU patient blood management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Diagnostic Test: transferrin saturationAll critically ill patients are eligible for the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All critically ill patients alive at ICU discharge
Key inclusion criteria (3 listed)
- Age ≥18 years
- ICU length of stay ≥72 hours
- Survival to ICU discharge
Key exclusion criteria (2 listed)
- Known hematologic diseases affecting erythropoiesis (e.g., aplastic anemia, myelodysplastic syndromes)
- Pregnancy
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 |
|---|---|---|
| transferrin saturationAlso: EQ-5D questionnaireAll patients will be tested for absolute or relative iron deficiency | Diagnostic test | Critically ill patients |
Primary outcome
Iron deficiency
Time frame: The day of ICU discharge (day 1)
iron deficiency will be defined as: TSAT <20%, regardless of ferritin levels and/or Ferritin <100 ng/mL
Iron deficiency at ICU admission
Time frame: ICU admission
iron deficiency will be defined as: TSAT <20%, regardless of ferritin levels and/or Ferritin <100 ng/mL
7 secondary outcomes
Proportion of patients receiving RBCT after ICU discharge
Time frame: 30-day
Hemoglobin level 28 days after ICU discharge
Time frame: up to 28-days after ICU discharge
Functional recovery
Time frame: up to 90-day after ICU discharge
Hospital readmission
Time frame: up to 180-days after ICU discharge
Mortality
Time frame: 30-day
mortality
Time frame: 90-day
mortality
Time frame: 180-day
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 24 Aug 2026.
- Individual participant dataSharing planned: Yes. IPD will be shared under reasonable requests
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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.
Policlinico Universitario Agostino Gemelli
Roma, Italy
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Post ICU Syndrome, run by Università degli Studi di Ferrara at 4 sites in 2 countries.
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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron deficiency (time frame: The day of ICU discharge (day 1)). The study lists 2 primary outcomes in all. 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 24 Aug 2026.