Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-04-16 @ 8:54 AM
Study NCT ID:
NCT02200159
Status:
UNKNOWN
Last Update Posted:
2014-11-26
First Post:
2014-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-25', 'studyFirstSubmitDate': '2014-06-30', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with failure of sedation with dexmedetomidine', 'timeFrame': 'at day 1', 'description': 'Number of patients with failure of sedation with dexmedetomidine (necessity to stop this sedation due to adverse event, RASS\\>+1, other) in ICU patients requiring such sedation during ICU stay.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse event of dexmedetomidine', 'timeFrame': 'at day 1'}, {'measure': 'Incidence of delirium and use of other sedative drugs', 'timeFrame': 'at day 1'}]}, 'conditionsModule': {'keywords': ['Sedation', 'Dexmedetomidine', 'ICU', 'Delirium'], 'conditions': ['Requiring Sedation in ICU', 'Adult Patients', 'Patient Covered by French Health Care System']}, 'descriptionModule': {'briefSummary': 'Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU', 'detailedDescription': 'Prospective clinical study in ICU with sedated ventilated patients with dexmedetomidine, establishing incidence of success, failure of moderate sedation or failure of dexmedetomidine, to evaluate the effectiveness of this drug sedation in moderate sedation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients ventilated requiring sedation in ICU with RASS objective more than -2', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Adult patients ventilated requiring sedation in ICU with RASS objective more than -2\n\nExclusion Criteria:\n\n* contraindication: intracranial lesion, hepatic failure\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02200159', 'briefTitle': 'Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU', 'orgStudyIdInfo': {'id': 'CHU-0197'}, 'secondaryIdInfos': [{'id': '2013-000960-26'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'dexmedetomidine', 'interventionNames': ['Drug: Sedation with dexmedetomidine']}], 'interventions': [{'name': 'Sedation with dexmedetomidine', 'type': 'DRUG', 'armGroupLabels': ['dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'overallOfficials': [{'name': 'Jean-Michel CONSTANTIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}