[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633891":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":26,"id":53,"slug":26,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":26,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":69,"conditions":70,"keywords":26,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intranasal insulin","EXPERIMENTAL","Intranasal insulin administered twice daily. Each administration consists of two sprays of 10 IU (0.1 ml) in alternating nostrils, totalling to 40 IU per day.",[13],"Drug: Intranasal insulin-40U",{"label":15,"type":16,"description":17,"interventionNames":18},"Intranasal placebo (NaCl 0.9%)","PLACEBO_COMPARATOR","Intranasal placebo (sodium chloride 0.9%) administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4 mL per day.",[19],"Drug: Intranasal sodium chloride 0.9%",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Intranasal insulin-40U","Intranasal isophane insulin administered twice daily. Each administration consists of two sprays of 10 IU (0.1 ml) in alternating nostrils, totalling to 40 IU per day.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Intranasal sodium chloride 0.9%","Intranasal sodium chloride 0.9% administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4mL per day.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Rens Kooken, MD","CONTACT","+3124361673","rens.kooken@radboudumc.nl",[38],{"facility":5,"status":26,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Nijmegen","Gelderland","6525GA","Netherlands",{"type":44,"coordinates":45},"Point",[46,47],5.85278,51.8425,{"lat":47,"lon":46},[50],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":52,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100633891",false,"NCT07532577","Intranasal Insulin to Prevent Intensive Care Unit Delirium","Intranasal Insulin for the Prevention of Delirium in ICU Patients Undergoing Elective Cardiac Surgery: a Randomized, Double-blind, Placebo-controlled Pilot Trial (INSPIRE)","INSPIRE","Inclusion Criteria:\n\n1. Age ≥65 years\n2. Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex cardiac surgery is defined as all cardiac on-pump procedures except for isolated CABG\n3. Able to receive intranasal spray (no obstructive nasal pathology precluding administration)\n4. Informed consent from patient\n\nExclusion Criteria:\n\n1. Delirium at hospital admission\n2. Non-complex or off-pump cardiac surgery\n3. Known allergy\u002Fhypersensitivity to insulin or formulation excipients\n4. Contra-indication for nasal administration (severe nasal pathology, recent nasal\u002Fsinus surgery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)\n5. Participating in other investigational medication trial","ALL","65 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67,68],"PHASE2","PHASE3","This study aims to assess the feasibility, tolerability, and exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass",[71],"Delirium - Postoperative","NOT_YET_RECRUITING","2026-04-09",{"date":75,"type":76},"2026-04-16","ACTUAL",{"date":78,"type":64},"2026-04-15",{"date":80,"type":64},"2026-08-15",{"name":5,"class":6},1]