Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-02 @ 6:32 AM
Study NCT ID:
NCT01291368
Status:
COMPLETED
Last Update Posted:
2012-10-22
First Post:
2011-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-19', 'studyFirstSubmitDate': '2011-01-20', 'studyFirstSubmitQcDate': '2011-02-07', 'lastUpdatePostDateStruct': {'date': '2012-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sedation level and Delirium', 'timeFrame': 'At least twice a day while in the ICU', 'description': 'Sedation assessed with RASS and delirium assessed with the CAM-ICU by the nurses at the ICU'}], 'secondaryOutcomes': [{'measure': 'Post Traumatic Stress Disorder', 'timeFrame': '2 and 6 month after ICU-discharge', 'description': 'Minimum 250 patients who accept phone interviews are called twice (after 2 and 6 month) to answer these questionnaires:\n\n* Intensive Care Unit - memory tool\n* Harvard Trauma Questionnaire (HTQ)\n* Major Depression Inventory (MDI)\n* State-Trait Anxiety Inventory Form Y (STAI)'}, {'measure': 'Health-related quality of life', 'timeFrame': '2 and 6 month after ICU-discharge', 'description': 'Minimum 250 patients who accept phone interviews are called twice (after 2 and 6 month) to answer the questionnaires:\n\n* Activities of daily living (ADL)\n* Short-form 36\n* Script Test (only after 2 month)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sedation', 'Delirium', 'PTSD', 'Depression', 'Anxiety', 'HRQoL', 'CAM-ICU', 'RASS', 'SF-36', 'ICU-memory tool', 'Antipsychotic Agents', 'Mobilization', 'ICU-nursing', 'ICU', 'intensive care', 'critical care', 'critical care nursing'], 'conditions': ['Delirium', 'Stress Disorders, Post-Traumatic']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate if sedation of Intensive Care Unit (ICU) patients influences the development of delirium during their ICU stay and if incidences of delirium have an impact on the development of Post-traumatic Stress-Disorder (PTSD).\n\nHypothesis 1:\n\nPatients who are minimally sedated, remember staying in ICU and experiences fewer episodes of delirium than patients that are heavily sedated\n\nHypothesis 2:\n\nFormer delirious patients are more likely to develop PTSD\n\nHypothesis 3:\n\nDelirium decreases health-related quality (HRQoL) of life after discharge', 'detailedDescription': 'Background:\n\nIt is known that ICU patients that experience delirium have longer hospital stay, higher mortality and morbidity. Other studies indicate that PTSD, dementia or depression may emerge after discharge from hospital.\n\nMethods according to hypothesis 1:\n\nDuring ICU stay: Measure sedation level \\& delirium. First follow-up 1-2 weeks after ICU: Memories\n\nAnalyses:\n\nData will be analyzed descriptive via EPIDATA and Stata Delirium is endpoint, defined as CAM-ICU positive. Sedation level is exposure variable.\n\nConfounders: priory antipsychotic treatment or hypertension,glasses or hearing aids,alcohol and tobacco abuse,degree of illness,age and sex.\n\nCorrelation between sedation level and memories will be calculated.\n\nMethods according to hypothesis 2:\n\nScreening for: PTSD, Depression, Anxiety\n\nAnalyses:\n\nPTSD is endpoint, and delirium is the exposure variable. Main confounders: Anxiety and Depression Mean of PTSD will be calculated with Confidence Interval to test any difference between experienced delirium or not.\n\nMethods according to hypothesis 3:\n\nMethod:Health-related quality of life is endpoint, Activities of daily living (ADL), Memories, and a Script Test (only after 2 month)\n\nAnalyses:\n\nMean of HRQoL will be calculated with Confidence Interval to test any difference between experienced delirium or not.\n\nConfounders: Diary and/or Follow up'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients at the ICUs ITA and 600 at Århus Sygehus, Denmark from September 2009 and at Hillerød Intensive, Denmark from 15th October 2010 to 1st October 2011.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU-stay \\> 48 hours\n\nExclusion Criteria:\n\n* Severe brain trauma\n* Non-Danish-speaking\n* Age \\< 18 years\n* Death (only hypothesis 2 and 3 in the study)'}, 'identificationModule': {'nctId': 'NCT01291368', 'briefTitle': 'Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Does Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care?', 'orgStudyIdInfo': {'id': '1-16-02-50-09'}}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'state': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital, Århus Sygehus', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '3400', 'city': 'Hillerød', 'state': 'Hillerød', 'country': 'Denmark', 'facility': 'Anæstesiologisk Afdeling, . Hillerød Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'overallOfficials': [{'name': 'Else Tønnesen, MD Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. of Anasthesia, Aarhus Universtyhospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Novo Nordic Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}