[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653032":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":42,"studyPopulation":46,"armGroups":47,"interventions":53,"overallOfficials":42,"centralContacts":42,"locations":61,"responsibleParty":127,"collaborators":42,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":133,"sex":139,"minAge":140,"maxAge":42,"enrollmentInfo":141,"targetDuration":42,"studyType":144,"phases":42,"briefSummary":145,"conditions":146,"keywords":151,"overallStatus":82,"whyStopped":42,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Università degli Studi di Ferrara","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":42},[9,13],{"measure":10,"description":11,"timeFrame":12},"Iron deficiency","iron deficiency will be defined as: TSAT \\\u003C20%, regardless of ferritin levels and\u002For Ferritin \\\u003C100 ng\u002FmL","The day of ICU discharge (day 1)",{"measure":14,"description":11,"timeFrame":15},"Iron deficiency at ICU admission","ICU admission",[17,20,24,28,32,35,39],{"measure":18,"description":18,"timeFrame":19},"Proportion of patients receiving RBCT after ICU discharge","30-day",{"measure":21,"description":22,"timeFrame":23},"Hemoglobin level 28 days after ICU discharge","Hemoglobin level at hospital discharge and\u002For 28 days after ICU discharge","up to 28-days after ICU discharge",{"measure":25,"description":26,"timeFrame":27},"Functional recovery","assessed using the EQ-5D questionnaire","up to 90-day after ICU discharge",{"measure":29,"description":30,"timeFrame":31},"Hospital readmission","Percentage of hospital readmission","up to 180-days after ICU discharge",{"measure":33,"description":34,"timeFrame":19},"Mortality","30-day mortality",{"measure":36,"description":37,"timeFrame":38},"mortality","90-day mortality","90-day",{"measure":36,"description":40,"timeFrame":41},"180-days mortality","180-day",null,{"allocation":42,"interventionModel":42,"interventionModelDescription":42,"primaryPurpose":42,"observationalModel":44,"timePerspective":45,"maskingInfo":42},"COHORT","PROSPECTIVE","All critically ill patients alive at ICU discharge",[48],{"label":49,"type":42,"description":50,"interventionNames":51},"Critically ill patients","All critically ill patients are eligible for the study",[52],"Diagnostic Test: transferrin saturation",[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"DIAGNOSTIC_TEST","transferrin saturation","All patients will be tested for absolute or relative iron deficiency",[49],[60],"EQ-5D questionnaire",[62,80,100,114],{"facility":63,"status":64,"city":65,"state":42,"zip":42,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Hospital Erasme","NOT_YET_RECRUITING","Brussels","Belgium","BE",{"type":69,"coordinates":70},"Point",[71,72],4.34878,50.85045,{"lat":72,"lon":71},[75],{"name":76,"role":77,"phone":78,"phoneExt":42,"email":79},"Fabio Silvio Taccone","CONTACT","+ 32 (0)2 541 33 87","Fabio.Taccone@ulb.be",{"facility":81,"status":82,"city":83,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Università di Ferrara","RECRUITING","Ferrara","44121","Italy","IT",{"type":69,"coordinates":88},[89,90],11.62057,44.83804,{"lat":90,"lon":89},[93,97],{"name":94,"role":77,"phone":95,"phoneExt":42,"email":96},"Alberto Fogagnolo, MD","+39 0532537000","alberto.fogagnolo@gmail.com",{"name":98,"role":77,"phone":42,"phoneExt":42,"email":99},"Savino Spadaro, PhD","savinospadaro@gmail.com",{"facility":101,"status":64,"city":102,"state":42,"zip":103,"country":85,"countryCode":86,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Policlinico Universitario Agostino Gemelli","Roma","00168",{"type":69,"coordinates":105},[106,107],11.10642,44.99364,{"lat":107,"lon":106},[110],{"name":111,"role":77,"phone":112,"phoneExt":42,"email":113},"Giorgia Spinazzola","06 3015.1","giorgia.spinazzola@policlinicogemelli.it",{"facility":115,"status":64,"city":116,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Anestesia e Rianimazione Cardio-Toraco-Vascolare","Siena",{"type":69,"coordinates":118},[119,120],11.33064,43.31822,{"lat":120,"lon":119},[123],{"name":124,"role":77,"phone":125,"phoneExt":42,"email":126},"Federico Franchi","0577 586819.","federico.franchi@unisi.it",{"type":128,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Alberto Fogagnolo","principal investigator","100653032","iron-deficiency-at-icu-discharge-100653032",false,"NCT07781540","Iron Deficiency at ICU Discharge","Iron Deficiency at ICU Discharge and Its Impact on Post-critical Illness Recovery. The IRON-ICU Study","IRON-ICU","Inclusion criteria:\n\n* Age ≥18 years\n* ICU length of stay ≥72 hours\n* Survival to ICU discharge\n\nExclusion criteria:\n\n* Known hematologic diseases affecting erythropoiesis (e.g., aplastic anemia, myelodysplastic syndromes)\n* Pregnancy","ALL","18 Years",{"count":142,"type":143},462,"ESTIMATED","OBSERVATIONAL","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.\n\nAnemia 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.\n\nAdult 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.\n\nThe primary objective is to determine the prevalence of iron deficiency (defined as TSAT \\\u003C20%) 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.\n\nThe 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.",[147,148,149,150],"Anemia","Post ICU Syndrome","Red Blood Cell Transfusions","Iron Deficiencies",[147,152],"Iron deficiencies","2026-08-20",{"date":155,"type":156},"2026-08-24","ACTUAL",{"date":158,"type":156},"2026-07-29",{"date":160,"type":143},"2028-01-30",{"name":5,"class":6},4]