Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2026-01-02 @ 9:06 AM
Study NCT ID:
NCT03091166
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-03-21', 'lastUpdatePostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30DM', 'timeFrame': '30 days after surgery', 'description': '30-day mortality'}, {'measure': 'Delirium', 'timeFrame': '30 days after surgery', 'description': 'Postoperative delirium'}], 'secondaryOutcomes': [{'measure': 'VIS', 'timeFrame': '5 days after surgery', 'description': 'Vasoactive- Inotropic Score'}, {'measure': 'MACCE', 'timeFrame': '30 days after surgery', 'description': 'Major adverse cardiac and cerebrovascular events'}, {'measure': 'Subsyndromal delirium', 'timeFrame': '30 days after surgery', 'description': 'Subsyndromal postoperative delirium'}, {'measure': 'AKI', 'timeFrame': '7 days after surgery', 'description': 'Acute kidney injury'}, {'measure': 'ICU-LOS', 'timeFrame': '7 days after surgery', 'description': 'Length of ICU stay'}, {'measure': 'H-LOS', 'timeFrame': '30 days after surgery', 'description': 'Hospital length of stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patient Outcome Assessment']}, 'descriptionModule': {'briefSummary': 'Investigation of effect of perioperative Dexmedetomedine administration on mortality, length of ICU and hospital stay, delirium onset, major adverse cardiac and cerebrovascular events, acute kidney injury in cardiac surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed agreement\n* Elective surgery\n* Use of CPB\n\nExclusion Criteria:\n\n* Previous prolonged immobilization\n* Reoperation'}, 'identificationModule': {'nctId': 'NCT03091166', 'briefTitle': 'Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Moscow Regional Research and Clinical Institute (MONIKI)'}, 'officialTitle': 'The Effect of Prophylactic Dexmedetomidine Administration on the Outcome in Patients Undergoing Surgery With Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'PD-CS-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'NO_INTERVENTION', 'label': 'No Dexmedetomidine'}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Dexdor'], 'armGroupLabels': ['Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '129110', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Valery Likhvantsev, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moscow Regional Clinical and Research Institute, Moscow, Russia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moscow Regional Research and Clinical Institute (MONIKI)', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior researcher', 'investigatorFullName': 'Oleg A. Grebenchikov', 'investigatorAffiliation': 'Moscow Regional Research and Clinical Institute (MONIKI)'}}}}