Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-29 @ 5:16 PM
Study NCT ID:
NCT03415061
Status:
UNKNOWN
Last Update Posted:
2021-10-21
First Post:
2018-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intranasal Insulin on POCD and POD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D006331', 'term': 'Heart Diseases'}], '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'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 494}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2018-01-23', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confusion Assessment method for the ICU', 'timeFrame': 'Up to 7 days after surgery', 'description': 'Postoperative Delirium is assessment'}, {'measure': 'Rey Auditory Verbal Leaning', 'timeFrame': 'up to 12 month', 'description': 'Episodic Memory Lowest score: 0 Highest Score: 15'}, {'measure': 'Rey-Osterrieth Complex Figure Test', 'timeFrame': 'up to 12 month', 'description': 'Episodic Memory Lowest score: 0 Highest Score: 8'}], 'secondaryOutcomes': [{'measure': 'Stroop Test', 'timeFrame': 'up to 12 month', 'description': 'Executive Function'}, {'measure': 'Trail Making Test', 'timeFrame': 'up to 12 month', 'description': 'Executive Function'}, {'measure': 'Tower of London test', 'timeFrame': 'up to 12 month', 'description': 'Executive Function'}, {'measure': 'Symbol Digit Modalities Test', 'timeFrame': 'up to 12 month', 'description': 'Information Processing Speed'}, {'measure': 'Boston Naming Test', 'timeFrame': 'up to 12 month', 'description': 'Language Lowest score: 0 Highest score: 60'}, {'measure': 'Clock Drawing Test', 'timeFrame': 'up to 12 month', 'description': 'Visuospatial Function Lowest score: 1 Highest score: 10'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium', 'Heart Diseases']}, 'descriptionModule': {'briefSummary': "Decline in cognitive function after surgery occurs most commonly in older patients and patients undergoing major surgeries, such as heart surgery. Postoperative Cognitive Dysfunction (POCD) may last a prolonged period of time while Postoperative Delirium (POD) is a more acute disturbance in attention, awareness and cognition. The cause of POCD and POD are not fully understood, however some of the pathophysiology of POCD is similar to that of Alzheimer's disease (AD).\n\nInsulin given intravenously during heart surgery has been shown to preserve short and long-term memory function after the operation. Clinical trials further demonstrated that insulin given via the nose (intranasal) improves memory performance of patients with AD or cognitive impairment suggests that intranasal insulin also could be a therapeutic option for POCD and POD.\n\nThis study is designed to examine the effect intranasal insulin on POCD and POD. The goal is to investigate whether administration of intranasal insulin during and after heart surgery improves cognitive function postoperatively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n•elective open heart surgery requiring cardiopulmonary bypass\n\nExclusion Criteria:\n\n* inability to provide informed consent\n* allergy to insulin\n* pregnancy\n* mother tongue other than English or French\n* visual or hearing impairment interfering with the ability to complete cognitive tests.'}, 'identificationModule': {'nctId': 'NCT03415061', 'briefTitle': 'Effect of Intranasal Insulin on POCD and POD', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Does Intranasal Insulin Administration Reduce the Incidence of Cognitive Dysfunction After Cardiac Surgery?', 'orgStudyIdInfo': {'id': '20184334'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal Insulin 40 IU', 'description': '40 IU of Humulin-R via nose Before surgery and everyday after surgery up to postoperative day 7', 'interventionNames': ['Drug: Regular Insulin, Human 100 UNT/ML']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intranasal Normal Saline', 'description': 'Normal Saline via nose Before surgery and everyday after surgery up to postoperative day 7', 'interventionNames': ['Drug: Normal Saline Flush, 0.9% Injectable Solution']}], 'interventions': [{'name': 'Regular Insulin, Human 100 UNT/ML', 'type': 'DRUG', 'otherNames': ['Humulin R'], 'description': '40 IU of Humulin-R to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery.', 'armGroupLabels': ['Intranasal Insulin 40 IU']}, {'name': 'Normal Saline Flush, 0.9% Injectable Solution', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery', 'armGroupLabels': ['Intranasal Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4A3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Hiroaki Sato, M.D.PhD', 'role': 'CONTACT', 'email': 'tamaki.sato@muhc.mcgill.ca', 'phone': '5149341934', 'phoneExt': '64275'}, {'name': 'Hiroaki Sato, M.D.PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Victoria Hospital McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Thomas Schricker, M.D., PhD.', 'role': 'CONTACT', 'email': 'thomas.schricker@mcgill.ca', 'phone': '5149341934'}, {'name': 'Hiroaki Sato, M.D., PhD.', 'role': 'CONTACT', 'email': 'hiroaki.sato2@mcgill.ca', 'phone': '5149341934'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hiroaki Sato, MD., PhD.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hiroaki Sato, MD., PhD.', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}