Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
Study NCT ID:
NCT06569992
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2024-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Etiology and Hemodynamic Instability in Brain Death
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001926', 'term': 'Brain Death'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003128', 'term': 'Coma'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2024-08-20', 'studyFirstSubmitQcDate': '2024-08-22', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Inotrope Exposure Score (TIES)', 'timeFrame': 'From beginning to vasoactive-inotropic drugs infusion until diagnosis of brain death, 10 days (with intermediate measurements every hours)', 'description': 'Dopamine dose (μg/kg/min) × \\[length of administration in days\\] + Dobutamine dose (μg/kg/min) × \\[length of administration in days\\] + 10 × Milrinone dose (μg/kg/min) × \\[length of administration in days\\] + 100 × Epinephrine dose (μg/kg/min) × \\[length of administration in days\\] + 100 × Norepinephrine dose (μg/kg/min) × \\[length of administration in days\\] + 10,000 × Vasopressin dose (U/kg/min) × \\[length of administration in days'}, {'measure': 'Vasoactive-Inotropic Score (VIS)', 'timeFrame': 'From beginning to vasoactive-inotropic drugs infusion until diagnosis of brain death, 10 days (with intermediate measurements every hours)', 'description': 'Dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain death', 'VIS', 'TIES'], 'conditions': ['Brain Death']}, 'referencesModule': {'references': [{'pmid': '10798503', 'type': 'RESULT', 'citation': 'Flowers WM Jr, Patel BR. Persistence of cerebral blood flow after brain death. South Med J. 2000 Apr;93(4):364-70.'}, {'pmid': '33069558', 'type': 'RESULT', 'citation': 'Belletti A, Lerose CC, Zangrillo A, Landoni G. Vasoactive-Inotropic Score: Evolution, Clinical Utility, and Pitfalls. J Cardiothorac Vasc Anesth. 2021 Oct;35(10):3067-3077. doi: 10.1053/j.jvca.2020.09.117. Epub 2020 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'Brain death is a complex and irreversible condition marked by the cessation of all brain activity. This retrospective study analyzes ICU patients who progressed from initial brain injury to brain death. The research focuses on demographic profiles, pharmacological interventions, laboratory data, and imaging findings to understand these cases clinical trajectories and therapeutic responses. Central to this study is evaluating cardiovascular support using the Vasoactive-Inotropic Score (VIS) and Total Inotrope Exposure (TIE) Score. This study explores the relationship between the etiology of brain death and the pharmacologic cardiovascular support administered, as quantified by VIS and TIES scores. This study seeks to enhance the management strategies and improve outcomes for patients diagnosed with brain death', 'detailedDescription': 'This study undertakes a comprehensive retrospective analysis of patients admitted to the intensive care unit (ICU) with an initial diagnosis of brain injury who subsequently progressed to brain death. The investigation will meticulously assess these patients, demographic profiles, pharmacological interventions, laboratory parameters, and radiological imaging findings. The overarching aim is to delineate the clinical trajectory and therapeutic responses of patients diagnosed with brain death, critically evaluating the complexities encountered during their management, and providing evidence-based insights to inform future treatment protocols.\n\nCentral to this study is the quantitative assessment of hemodynamic stability using the Vasoactive-Inotropic Score (VIS) and the Total Inotrope Exposure (TIE) Score. The VIS will quantify the need for vasopressor and inotropic support, reflecting the severity of cardiovascular instability. At the same time, the TIE Score will measure the cumulative exposure to inotropic agents, providing a comprehensive evaluation of the overall cardiovascular burden. The primary aim of this study is to explore the relationship between the etiology of brain death and the pharmacologic cardiovascular support administered, as quantified by VIS and TIES scores. Additionally, the study will assess how these pharmacologic interventions differ in patients who have undergone decompressive surgery compared to those who have not.\n\nThis thesis aspires to make a significant contribution to the optimization of management strategies for patients diagnosed with brain death, aiming to enhance clinical decision-making and improve patient outcomes in this critically ill cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will retrospectively analyze data from patients diagnosed with brain death and followed in the Anesthesiology and Intensive Care Units at University of Health Science Antalya Training and Research Hospital between January 1, 2019, and December 31, 2023. Patients will be categorized based on the etiological cause of brain injury into the following groups: those with spontaneous subarachnoid hemorrhage and spontaneous intracerebral hemorrhage (Group 1), those with traumatic intracranial hemorrhage (Group 2), and those with ischemic cerebrovascular events and hypoxic-ischemic brain injury (including cases of cardiac arrest, drowning, carbon monoxide poisoning, etc.) (Group 3).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥18 years) admitted to the intensive care unit (ICU) at Antalya Training and Research Hospital between 2019 and 2023.\n* Patients with a confirmed diagnosis of brain death based on a positive apnea test and/or neuroimaging findings.\n* Patients with comprehensive and complete clinical data available in the hospital\\'s medical records.\n\nExclusion Criteria:\n\n* Patients under the age of 18.\n* Patients with incomplete clinical data in the medical records.\n* Patients with moderate to severe heart failure.\n* Patients with major organ injuries in addition to traumatic intracranial hemorrhage.\n* Pregnant patients.\n* Patients with significant comorbidities that could impact hemodynamic stability.\n* Patients experiencing hemodynamic instability due to septic shock.\n* Patients who were initially treated for brain injury at external facilities and later transferred to our hospital.'}, 'identificationModule': {'nctId': 'NCT06569992', 'briefTitle': 'Etiology and Hemodynamic Instability in Brain Death', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Antalya Training and Research Hospital'}, 'officialTitle': 'Comparison of the Relationship Between Etiology and Hemodynamic Instability in Brain Death: VIS and TIES', 'orgStudyIdInfo': {'id': '2024-CeylanM.Braindeath'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Spontaneous subarachnoid hemorrhage and spontaneous intracerebral hemorrhage', 'interventionNames': ['Other: VIS, TIES']}, {'label': 'Group 2', 'description': 'Traumatic intracranial hemorrhage', 'interventionNames': ['Other: VIS, TIES']}, {'label': 'Group 3', 'description': 'Ischemic cerebrovascular events and hypoxic-ischemic brain injury (including cases of cardiac arrest, drowning, carbon monoxide poisoning, etc.)', 'interventionNames': ['Other: VIS, TIES']}], 'interventions': [{'name': 'VIS, TIES', 'type': 'OTHER', 'description': 'The vasopressor and inotropic drug dosages administered during the follow-up of these patients will be recorded, and the Vasoactive-Inotropic Score (VIS) and Total Inotrope Exposure Score (TIES) will be calculated.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07100', 'city': 'Antalya', 'state': 'Muratpasa', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Nilgun Kavrut Ozturk, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Health Science Antalya Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor MD', 'investigatorFullName': 'Nilgun Kavrut Ozturk', 'investigatorAffiliation': 'Antalya Training and Research Hospital'}}}}