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NCT Number: NCT07781540

Iron Deficiency at ICU Discharge

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Erasme, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • ICU length of stay ≥72 hours
  • Survival to ICU discharge

Exclusion criteria

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

Treatment and study plan

transferrin saturation

Diagnostic Test

All patients will be tested for absolute or relative iron deficiency

Other names: EQ-5D questionnaire

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Proportion of patients receiving RBCT after ICU discharge

    Time frame: 30-day

    Proportion of patients receiving RBCT after ICU discharge

  2. Hemoglobin level 28 days after ICU discharge

    Time frame: up to 28-days after ICU discharge

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

  3. Functional recovery

    Time frame: up to 90-day after ICU discharge

    assessed using the EQ-5D questionnaire

  4. Hospital readmission

    Time frame: up to 180-days after ICU discharge

    Percentage of hospital readmission

  5. Mortality

    Time frame: 30-day

    30-day mortality

  6. mortality

    Time frame: 90-day

    90-day mortality

  7. mortality

    Time frame: 180-day

    180-days mortality

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study title

Iron Deficiency at ICU Discharge and Its Impact on Post-critical Illness Recovery. The IRON-ICU Study

Acronym: IRON-ICU

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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