Loading search results
IRON-ICU
Sponsor study identifier
observational
462
2 countries
4
Study Start
July 29, 2026
Actual (reported)Primary Completion
July 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 29, 2026
Actual (reported)July 29, 2026
Actual (reported)August 24, 2026
Actual (reported)July 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Iron deficiency
iron deficiency will be defined as: TSAT \<20%, regardless of ferritin levels and/or Ferritin \<100 ng/mL
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
ICU admission
Proportion of patients receiving RBCT after ICU discharge
30-day
All critically ill patients are eligible for the study
All patients will be tested for absolute or relative iron deficiency
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All critically ill patients alive at ICU discharge
Hospital Erasme
Brussels, Belgium
Università di Ferrara
Ferrara, Ferrara, 44121, Italy
First Submitted
July 29, 2026
First Posted
August 24, 2026
Study Start
July 29, 2026
Actual (reported)Primary Completion
July 30, 2027
EstimatedHemoglobin level 28 days after ICU discharge
up to 28-days after ICU discharge
Functional recovery
up to 90-day after ICU discharge
Hospital readmission
up to 180-days after ICU discharge
Mortality
30-day
Contact the study team to confirm eligibility.
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Anestesia e Rianimazione Cardio-Toraco-Vascolare
Siena, Italy
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 24, 2026
Record last verified: 2026-08
IPD will be shared under reasonable requests
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: