[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614200":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":11,"centralContacts":16,"locations":10,"responsibleParty":22,"collaborators":10,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":30,"eligibilityCriteria":31,"healthyVolunteers":26,"sex":32,"minAge":33,"maxAge":10,"enrollmentInfo":34,"targetDuration":10,"studyType":37,"phases":10,"briefSummary":38,"conditions":39,"keywords":42,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":10},{"fullName":5,"class":6},"University Hospital Tuebingen","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":10},"adults with elective valve or bypass surgery using heart-lung machine",null,[12],{"name":13,"affiliation":14,"role":15},"Peter Rosenberger, Prof. Dr.","Universitaetsklinikum Tuebingen","STUDY_DIRECTOR",[17],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Christian Marx, B.A.","CONTACT","+4970712986724","christian.marx@med.uni-tuebingen.de",{"type":23,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100614200","verification-of-a-new-predictive-delirium-score-in-adults-with-elective-cardiac-valve-or-bypass-surgery-with-perioperative-use-of-a-heart-lung-machine-a-monocentric-pilot-observational-study-100614200",false,"NCT07276503","Verification of a New Predictive Delirium Score in Adults With Elective Cardiac Valve or Bypass Surgery With Perioperative Use of a Heart-lung Machine; a Monocentric Pilot Observational Study","Predictors for the Development of Perioperative Delirium in Adult Patients Undergoing Elective Cardiac Surgery","MO-FA2-(TB)","Inclusion Criteria:\n\n* Elective cardiac surgery Heart valve surgery, bypass surgery with CPB\n* Length of stay in ICU \\> 48 hours\n* Age ≥18 years\n* Fluent German language skills\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Lack of capacity to give consent\n* Emergency\n* Readmission to intensive care unit\n* OPCAB surgery, microsurgical procedure","ALL","18 Years",{"count":35,"type":36},100,"ESTIMATED","OBSERVATIONAL","Basics (state of scientific knowledge):\n\nDelirium is an acute disturbance of consciousness and attention that develops over a short period of time and fluctuates in severity. It is accompanied by a deterioration in cognitive performance, such as memory deficits, disorientation, and speech and thinking disorders, which significantly exceed the degree of any pre-existing limitations . Surgery and intensive medical treatment are considered to be two of the triggers.\n\nIn cardiac surgery, the incidence is reported to be between 10 and 50%, depending on the patient population. Delirium occurs approximately 3-4 days after surgery and lasts for several days. Relevant factors in the cardiac surgery population include age, duration of aortic clamping time or surgical technique, pre-existing conditions such as the extent of heart failure (EuroScore), diabetes mellitus, mental and cognitive impairments, or carotid stenosis.\n\nBoth current studies and current recommendations emphasize prevention and the lack of successful treatment options. Preventive measures are primarily investigated in packages of measures. The study presented here aims to define risk populations and test the sensitivity and specificity of the MO-FA2-(TB) score for the development of delirium.\n\nObjectives of the study:\n\nVerification of the predictive score \"MO-FA2-(TB)\" for the development of postoperative delirium Recording of delirium and associated influencing factors and endpoints\n\nCategories examined in the score:\n\nMemory using a list of words that must be memorized and repeated after a few minutes Orientation by asking about the year, month, date, day of the week, city, and location Frailty using the ASA score Use of heart-lung machine Incision-suture time\n\nStudy duration (for individual subjects):\n\npostoperative intensive care stay up to and including day 10\n\nStudy population Patients who have to undergo cardiac surgery with CPB\n\nInclusion criteria:\n\nElective cardiac surgery Heart valve surgery, bypass surgery with CPB Length of stay in ICU \\> 48 hours Age ≥18 years Fluent German language skills\n\nExclusion criteria:\n\nAge \\\u003C18 years Lack of capacity to give consent Emergency Readmission to intensive care unit OPCAB surgery, microsurgical procedure\n\nRecruitment: Information provided the day before surgery based on the surgical schedule If consent is given, score is recorded If ICU stay \\>48 hours, treatment data is recorded, otherwise exclusion Data collection up to and including d10\n\nTreatment data collected:\n\nPreoperative data, including ejection fraction, aids, abuse, scores collected (\"4AT test\" for rapid assessment of delirium and cognitive impairment, \"MO-FA2-(TB)\", \"geriatric check\" for identifying a geriatric patient) Intraoperative data, including duration of surgery, duration of heart-lung machine, acidosis Postoperative data in ICU, including delirium scores (ICDSC, CAM-ICU), days on ventilation, days of treatment, fluid intake, medication related to delirium, organ replacement therapy such as dialysis\n\nNumber of cases: Approx. 100 patients\n\nMethodology Monocentric, observation",[40,41],"Emergence Delirium","Postoperative Delirium",[43,44,45,46,47,48,30],"predicitve","delirium","postoperative","valve surgery","bypass surgery","Score","NOT_YET_RECRUITING","2026-03-05",{"date":52,"type":53},"2026-03-06","ACTUAL",{"date":55,"type":36},"2026-03-09",{"date":57,"type":36},"2028-05-30",{"name":5,"class":6}]