Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-01 @ 1:26 PM
Study NCT ID:
NCT01862302
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2013-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006220', 'term': 'Haloperidol'}], 'ancestors': [{'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2013-05-09', 'studyFirstSubmitQcDate': '2013-05-22', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'An economic analysis will be completed to determine if Haloperidol prophylaxis resulted in any cost savings', 'timeFrame': 'Participants will be followed for the duration of their hospital stay to a maximum of 30 days'}], 'primaryOutcomes': [{'measure': 'Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery', 'timeFrame': 'Participants will be followed for the duration of their hospital stay to a maximum of 30 days.', 'description': 'If a participant does not develop delirium post operatively, then the confusion assessment method (CAM)will be monitored for 24 hours after the study medication ends. Patients will be followed up until seven days or until discharge if no delirium occurs, or if delirium is detected, up to 30 days or until discharge'}, {'measure': 'Safety monitoring of low dose Haloperidol use in patients post cardiac surgery', 'timeFrame': 'Participants will be followed for the duration of their hospital stay to a maximum of 30 days', 'description': 'If a participant does not develop delirium post operatively, then the confusion assessment method (CAM)will be monitored for 24 hours after the study medication ends. Patients will be followed up until seven days or until discharge if no delirium occurs, or if delirium is detected, up to 30 days or until discharge'}], 'secondaryOutcomes': [{'measure': 'The incidence of delirium', 'timeFrame': 'Participants will be followed for the duration of their hospital stay to a maximum of 30 days'}, {'measure': 'Delirium severity', 'timeFrame': 'Participants will be followed for the duration of their hospital stay to a maximum of 30 days'}, {'measure': 'Total length of stay (LOS), with breakdown for intensive care unit (ICU) days and ward days', 'timeFrame': 'Participants will be followed for the duration of their hospital stay to a maximum of 30 days'}, {'measure': 'Duration of delirium', 'timeFrame': 'Participants will be followed for the duration of their hospital stay to a maximum of 30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prevention delirium', 'Cardiac surgery'], 'conditions': ['Postoperative Confusion']}, 'descriptionModule': {'briefSummary': 'Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce the incidence, duration, and severity of post cardiotomy delirium?', 'detailedDescription': 'Pilot study for feasibility and safety, n = 40, haloperidol 1mg vs. placebo BID administered night before and day of surgery, then continued for total 72hrs post-op, if delirium occurs study drug is stopped and usual standard of care implemented by MRP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Greater than or equal to 70 years of age, undergoing a median sternotomy OR 60-69yrs of age with one or more of the risk factors:\n\n * TIA/Stroke;\n * Euroscore greater than or equal to 5;\n * abnormal clock draw.\n\nExclusion Criteria:\n\n* Parkinsonism,\n* on any antipsychotic medications pre-op,\n* active delirium,\n* emergent surgery,\n* Haloperidol allergy,\n* schizophrenia,\n* prolonged QTc.'}, 'identificationModule': {'nctId': 'NCT01862302', 'acronym': 'HALPCARD', 'briefTitle': 'Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium: A Randomized Placebo-Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'HALPCARD-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Haloperidol', 'description': 'Haloperidol 1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery', 'interventionNames': ['Drug: Haloperidol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Haloperidol', 'type': 'DRUG', 'otherNames': ['Haldol'], 'description': '1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery', 'armGroupLabels': ['Haloperidol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton General Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Andre Lamy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Andre Lamy, MD, FRCSC, MHSc, Cardiac Surgeon', 'investigatorFullName': 'Andre Lamy', 'investigatorAffiliation': 'McMaster University'}}}}