Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-10 @ 3:48 PM
Study NCT ID:
NCT02916069
Status:
UNKNOWN
Last Update Posted:
2017-07-06
First Post:
2016-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi Modal Brain Monitoring and Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017585', 'term': 'Ultrasonography, Doppler, Transcranial'}, {'id': 'D056805', 'term': 'Consciousness Monitors'}], 'ancestors': [{'id': 'D004453', 'term': 'Echoencephalography'}, {'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2016-09-16', 'studyFirstSubmitQcDate': '2016-09-25', 'lastUpdatePostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'S100 protein', 'timeFrame': 'up to 24 hours', 'description': 'S100 protein (marker of brain injury)'}], 'secondaryOutcomes': [{'measure': 'Mini-mental state examination', 'timeFrame': 'up to 30 days after surgery'}, {'measure': 'Western perioperative neurological scale', 'timeFrame': 'up to 30 days after surgery'}, {'measure': 'Major neurological out come as stoke', 'timeFrame': 'up to 30 days after surgery'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': 'up to 30 days after surgery'}, {'measure': 'Hospital stay', 'timeFrame': 'up to 30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Spectroscopy', 'Transcranial Doppler', 'Bispectral index', 'Cardiac surgery'], 'conditions': ['Intraoperative Neurophysiological Monitoring']}, 'descriptionModule': {'briefSummary': 'Multimodal brain monitoring is feasible and can be used in formulating therapeutic strategies during cardiac surgery. Such monitoring may help to improve patient outcome and to reduce costs after cardiac surgery with CPB.', 'detailedDescription': 'The aim of this study is to use a combination of brain monitoring {Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), bispectral index (BIS)} to formulate therapeutic strategies based on these monitors and to evaluate the impact on patient outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective cardiac surgery with cardiopulmonary bypass\n* Valve replacement\n* Coronary artery bypass\n\nExclusion Criteria:\n\n* Emergency surgery\n* Hepatic\n* Renal impairment\n* Diabetes Mellitus'}, 'identificationModule': {'nctId': 'NCT02916069', 'briefTitle': 'Multi Modal Brain Monitoring and Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Impact Multi Modal Brain Monitoring on Patient Out Come After Adult Cardiac Surgery', 'orgStudyIdInfo': {'id': 'IRB00008715621'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 (Multimodal brain monitoring)', 'description': 'Patients will be monitored with combination of brain monitoring; Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), and Bispectral index (BIS). Interference will be done to optimize the medical condition based on such monitors.', 'interventionNames': ['Device: Nearinfrared Spectroscopy (NIRS)', 'Device: Transcranial Doppler (TCD)', 'Device: Bispectral index (BIS)']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2', 'description': 'Patients will be monitored without any interference based on such monitors'}], 'interventions': [{'name': 'Nearinfrared Spectroscopy (NIRS)', 'type': 'DEVICE', 'description': 'Patients will be monitored and interference will be done to optimize the medical condition based on such monitor', 'armGroupLabels': ['Group 1 (Multimodal brain monitoring)']}, {'name': 'Transcranial Doppler (TCD)', 'type': 'DEVICE', 'description': 'Patients will be monitored and interference will be done to optimize the medical condition based on such monitor', 'armGroupLabels': ['Group 1 (Multimodal brain monitoring)']}, {'name': 'Bispectral index (BIS)', 'type': 'DEVICE', 'description': 'Patients will be monitored and interference will be done to optimize the medical condition based on such monitor', 'armGroupLabels': ['Group 1 (Multimodal brain monitoring)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74111', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sayed K Abd-Elshafy, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of medicine Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mohamed Ali, PhD. MD', 'role': 'CONTACT', 'email': 'msali58@hotmail.com', 'phone': '0020882413201'}, {'name': 'Sayed K Abd-Elshafy, MD', 'role': 'CONTACT', 'email': 'sayed_k_72@yahoo.com', 'phone': '0020882413201'}], 'overallOfficials': [{'name': 'Mohamed Ali, PhD. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'associate professor of anesthesia and critical care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University', 'investigatorFullName': 'Dr Mohamed Shaaban Ali, PhD, MD', 'investigatorAffiliation': 'Assiut University'}}}}