Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-03-04 @ 1:34 PM
Study NCT ID:
NCT03390751
Status:
UNKNOWN
Last Update Posted:
2020-07-30
First Post:
2017-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atropine Weight and Risk of Postoperative Confusion in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003221', 'term': 'Confusion'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2018-01-03', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between atropine load of medications on the risk of postoperative confusion', 'timeFrame': 'up to 7 days', 'description': "Occurrence of a postoperative confusion syndrome performed by Confusion Assessment Method (CAM) scale once a day. The CAM is a validated scale as a diagnostic scale for confusional syndrome at the patient's bedside with four parts : 1) confusion and fluctuation of symptoms, 2) inattention, 3) disorganization of thought, 4) disorder of consciousness."}, {'measure': 'Atropinic load of drugs', 'timeFrame': 'up to 7 days', 'description': 'The DURAN scale is the most recent and most comprehensive atropine load evaluation scale. This scale classifies the evaluated drugs into three categories: no anticholinergic power (atropine weight = 0), low anticholinergic activity (atropine weight = 1), high atropinic power (atropine weight = 3). All drugs received by the patient during 7 days will be classified with the Duran scale.'}], 'secondaryOutcomes': [{'measure': 'Duration of hospitalization', 'timeFrame': 'Up to discharge, an average of ten days', 'description': 'Number of days of hospitalization (days) between surgery and discharge. Association between atropinic load of drugs and duration of hospitalization will be evaluated.'}, {'measure': 'Autonomy', 'timeFrame': 'Month 3', 'description': 'Description of autonomy of the patient at three months of surgery evaluated by the Activity Daily Living scale (ADL). The ADL scale evaluates activities of daily living: washing, dressing, going to the bathroom, ensuring transfers, continence and food. Each item is rated according to a level of dependence: independent (1 point), with assistance (0.5 points), unable to achieve (0 points). A total of 6 points indicates a total autonomy, and 0 a total dependency.'}, {'measure': 'Cognitive dysfunction', 'timeFrame': 'baseline', 'description': 'Appearance postoperative cognitive dysfunction by the Mini Mental State (MMS). the total score of MMS wil be collected.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atropinic drugs', 'confusion', 'elderly patients'], 'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The identification of a high atropine load of treatment received during hospitalization as a predictor of postoperative confusion could have various benefits:\n\n* Pharmacoepidemiological: identify factors associated with postoperative confusion\n* Clinics: by favoring treatments with a low atropine load during anesthesia, the management of patients hospitalized in orthopedics. Similarly, stopping or re-evaluating treatments with a high atropine weight for scheduled surgery is an easy step to take.\n* Socio-economic: by reducing the costs related to the occurrence of a confusional syndrome (over-treatment, prolonged hospital stay, loss of autonomy, institutionalization of patients...).\n\nIn total, the present study would improve the daily management of hospitalized patients and the practices of clinicians, by offering a decision-making aid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The recruitment of patients will be ensured from the consultation of anesthesia or the entry into hospitalization by the anesthesia team of the orthopedic surgery department of the Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the orthopedic department for surgical management of a fracture of the upper end of the femur in emergency or for the installation of a hip or knee prosthesis\n* Patient able to understand and respond to the protocol\n* No opposition to the collection of data of the patient or his / her designee\n\nExclusion Criteria:\n\n* Pre-existing confusion to surgery, detected by the CAM scale\n* Serious or moderate head trauma less than three months old\n* Removing / installing prosthesis.'}, 'identificationModule': {'nctId': 'NCT03390751', 'acronym': 'ATROPAGE', 'briefTitle': 'Atropine Weight and Risk of Postoperative Confusion in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Atropine Weight and Risk of Postoperative Confusion After Hip Fracture Surgery or Prosthetic Surgery of the Lower Limb, in the Elderly', 'orgStudyIdInfo': {'id': 'RC31/17/0202'}, 'secondaryIdInfos': [{'id': '2017-A01847-46', 'type': 'REGISTRY', 'domain': 'ANSM Register'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aged patients', 'description': 'Data collection of patients admitted to the orthopedic department of the University Hospital of Toulouse for surgical management of a fracture of the upper end of the femur in emergency or for the installation of a hip or knee prosthesis.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'The collection of data will be done by interrogation of the patient and his family / entourage and rereading of medical records', 'armGroupLabels': ['Aged patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent Minville, MD', 'role': 'CONTACT'}], 'facility': 'Pierre-Paul-Riquet University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Vincent Minville, MD PhD', 'role': 'CONTACT', 'email': 'minville.v@chu-toulouse.fr', 'phone': '33-5 61 32 27 91'}, {'name': 'Marie PIEL-JULIAN', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Vincent Minville', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}