Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-03-14 @ 5:31 AM
Study NCT ID:
NCT03114904
Status:
COMPLETED
Last Update Posted:
2020-07-20
First Post:
2017-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013375', 'term': 'Substance Withdrawal Syndrome'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-17', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal', 'timeFrame': '3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Withdrawal Syndrome', 'Cerebral Lesion']}, 'descriptionModule': {'briefSummary': 'The withdrawal syndrome in benzodiazepines and morphine is common in intensive care, the incidence is estimated at 32.1%.\n\nCerebrospatized patients are probably more prone to withdrawal because they require high doses of sedation.\n\nMoreover, this syndrome is probably deleterious on the cerebral hemodynamics (high point of the therapeutic management).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major Patient\n* Admitted in Neuroreanimation\n* Cerebroséé (TC-HSA-AVC)\n* Mono or multi failing\n* After a neurosedation ≥ 3 days by hypnotic type benzodiazepine (Midazolam®) and morphinomimetic (Sufentanyl®) in IVSE\n* Affiliation to Social Security\n* Agreement of the person of confidence\n\nExclusion Criteria:\n\n* Addiction to opiates, cocaine or cannabis\n* Neurological Pathology Before Hospitalization\n* Patient suffering from cardiac arrest\n* Pregnant woman\n* Sedation window\n* Patient under tutelage or curatorship or deprived of public law'}, 'identificationModule': {'nctId': 'NCT03114904', 'acronym': 'NEUROSEV', 'briefTitle': 'Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses: Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'PI2015_843_0019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '"Usual" weaning management', 'interventionNames': ['Other: Variation of Jasinski score between H0 (stop of sedatives) and H6']}, {'type': 'OTHER', 'label': 'Introduction to H2 for the discontinuation of therapeutics', 'interventionNames': ['Other: Variation of Jasinski score between H0 (stop of sedatives) and H6']}], 'interventions': [{'name': 'Variation of Jasinski score between H0 (stop of sedatives) and H6', 'type': 'OTHER', 'description': 'To compare the effectiveness of a withdrawal management protocol with the usual management in cerebral patients (Subarachnoid haemorrhage (HSA), stroke and head trauma (CT))', 'armGroupLabels': ['"Usual" weaning management', 'Introduction to H2 for the discontinuation of therapeutics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'country': 'France', 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}