Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-04-12 @ 6:36 PM
Study NCT ID:
NCT00242151
Status:
UNKNOWN
Last Update Posted:
2006-10-12
First Post:
2005-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Delirium in Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'lastUpdateSubmitDate': '2006-10-11', 'studyFirstSubmitDate': '2005-10-18', 'studyFirstSubmitQcDate': '2005-10-18', 'lastUpdatePostDateStruct': {'date': '2006-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Delirium, Confusion, Cardiac Surgery, Organic Brain Injury, Diffusion Weighted Magnetic Resonance Imaging (DW-MRI)'], 'conditions': ['Heart Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine prevalence of postoperative delirium and confusion in patients undergoing cardiac surgery. This proposal is a pilot study designed to evaluate effect of cardiac surgery on prevalence of delirium and confusion.\n\nThe primary aim is to evaluate prevalence of delirium and confusion in patients undergoing cardiac surgery and to determine risk factors for this condition.\n\nA secondary aim is to evaluate organic brain injury by early postoperative diffusion weighted magnetic resonance imaging (DW-MRI) in patients who develop delirium and confusion.\n\nThe hypothesis to be tested is that patients with postoperative delirium and confusion have high incidence of organic brain injury as detected by DW-MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* All patients undergoing cardiac surgery in our institute in 2 year period\n* Signed informed consent\n\nExclusion criteria:\n\n* Past history of transient ischemic attacks, stroke, symptomatic carotid artery disease.\n* Past history of psychiatric disorders\n* History of alcohol and drug abuse\n* History of severe kidney or liver disease (creatinine \\>2.5mg/dL and bilirubin \\> 2mg/dL)\n* Known contraindications to MRI'}, 'identificationModule': {'nctId': 'NCT00242151', 'briefTitle': 'Prevalence of Delirium in Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Prevalence of Delirium in Patients Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'UHN REB 05-0223-AE'}}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jo A Carroll, RN', 'role': 'CONTACT', 'email': 'jo.carroll@uhn.on.ca', 'phone': '416-340-4800', 'phoneExt': '3243'}, {'name': 'George N Djaiani, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Susan Abbey, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jacek M Karski, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Toronto General Hospital, University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Jo A Carroll, RN', 'role': 'CONTACT', 'email': 'jo.carroll@uhn.on.ca', 'phone': '416-340-4800', 'phoneExt': '3243'}], 'overallOfficials': [{'name': 'Rita Katznelson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto General Hospital, University Health Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}}}}