Iron Deficiency at ICU Discharge

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversità degli Studi di Ferrara

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

ICU length of stay ≥72 hours

Survival to ICU discharge

Disqualifiers

Known hematologic diseases affecting erythropoiesis (e.g., aplastic anemia, myelodysplastic syndromes)

Pregnancy

Trial population

All critically ill patients alive at ICU discharge

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • transferrin saturation

    Diagnostic test

    All patients will be tested for absolute or relative iron deficiency

Treatment groups

462 Participants
are divided into 1 treatment group
Group A: Critically ill patients1 intervention

Trial outcomes

Primary outcomes

1

Iron deficiency

iron deficiency will be defined as: TSAT \<20%, regardless of ferritin levels and/or Ferritin \<100 ng/mL

Time frame
The day of ICU discharge (day 1)
2

Iron deficiency at ICU admission

iron deficiency will be defined as: TSAT \<20%, regardless of ferritin levels and/or Ferritin \<100 ng/mL

Time frame
ICU admission

Secondary outcomes

1

Proportion of patients receiving RBCT after ICU discharge

Proportion of patients receiving RBCT after ICU discharge

Time frame
30-day
2

Hemoglobin level 28 days after ICU discharge

Hemoglobin level at hospital discharge and/or 28 days after ICU discharge

Time frame
up to 28-days after ICU discharge
3

Functional recovery

assessed using the EQ-5D questionnaire

Time frame
up to 90-day after ICU discharge
4

Hospital readmission

Percentage of hospital readmission

Time frame
up to 180-days after ICU discharge

Other outcomes

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