[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515402":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":51,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":24,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University Hospital, Caen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"\"overdosed\" group","EXPERIMENTAL","The experimental group will be made up of falling patients recruited for whom at least one psychoactive drug has been measured in a concentration higher than the usual therapeutic ranges.",[13],"Biological: Blood sampling for psychoactive drugs dosage",{"label":15,"type":6,"description":16,"interventionNames":17},"\"non-overdosed\" group","The control group will be made up of falling patients recruited for whom none of the psychoactive drugs have been measured in supra-therapeutic concentrations (therefore concentrations measured therapeutic or infra-therapeutic)",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","Blood sampling for psychoactive drugs dosage","4 blood samples for psychoactive drugs identification and dosage will be taken on arrival at the emergency room during fall management",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Véronique Lelong-Boulouard, PhD","Caen Normandie Universitary Hospital Center","STUDY_DIRECTOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","0231063341","lelongboulouard-v@chu-caen.fr",{"name":36,"role":32,"phone":24,"phoneExt":24,"email":37},"Cédric Villain, PhD","villain-c@chu-acen.fr",[39],{"facility":40,"status":41,"city":42,"state":24,"zip":24,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":24},"Caen University Hospital","RECRUITING","Caen","France","FR",{"type":46,"coordinates":47},"Point",[48,49],-0.35912,49.18585,{"lat":49,"lon":48},{"type":52,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100515402","relation-between-psychoactive-drugs-overdosage-and-severity-of-falls-in-elderly-people-100515402",false,"NCT05991037","Relation Between Psychoactive Drugs Overdosage and Severity of Falls in Elderly People","Consequence of Plasma Concentrations of Psychoactive Drugs Located Beyond Therapeutic Ranges on Severity of Falls in Patients Over 75 Years Old","MEDIFALL","Inclusion Criteria:\n\n* Patient (male, female) aged 75 and over admitted to the emergency room for a fall and for whom hospitalization (in geriatrics or not) after going to the emergency room is planned\n* Patient consuming at least one psychoactive drug from the list provided in the protocol\n* Patient able to move before hospitalization with or without technical assistance\n* Patient who signed the consent\n* Patient subject to the social security system\n\nExclusion Criteria:\n\n* Patient not requiring hospitalization after going to the emergency room\n* Patient having fallen for more than 12 hours before inclusion in the study (time of sampling) \\[risk of excessive elimination of certain drugs with short half-lives\\]\n* Parkinsonian patient or patient who has fallen following a convulsive attack\n* Patient with a life-threatening prognosis in the very short term (state of shock, palliative care planned from the emergency room)\n* Patient in wheelchair or bedridden\n* Adult under legal protection, guardianship, curators\n* Patient not understanding the French language","ALL","75 Years",{"count":64,"type":65},400,"ESTIMATED","INTERVENTIONAL",[68],"NA","There are many epidemiological data on the relationship between the number or nature of psychoactive medications used and the risk of falling in elderly, but very little on the relationship between the amount of psychoactive medication actually present in the blood and the severity of the fall. However, the inevitable drug-drug interactions related to polypharmacy and the pharmacokinetic modifications related to old age may lead plasma overdose situations which can potentiate the risk of falls but also aggravate these consequences. The investigators therefore propose a study with the objective of verifying whether the proportion of falls with serious traumatic consequences is more frequent in patients over 75 years old, presenting plasma overdoses of psychoactive drugs (plasma concentrations higher than the usual therapeutic concentrations) in regard to those between therapeutic ranges.\n\nThe aim of this work is to verify if the falls present more severe characters when the psychoactive drug concentrations are beyond the usual therapeutic ranges.",[71],"Fall",[73,74,75,76,77],"fall","psychoactive drugs","old patients","prescription","plasmatic concentrations","2025-07-22",{"date":80,"type":81},"2025-07-25","ACTUAL",{"date":83,"type":81},"2024-05-22",{"date":85,"type":65},"2028-05-30",{"name":5,"class":6},1]