Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT05168059
Status:
COMPLETED
Last Update Posted:
2021-12-23
First Post:
2021-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clevidipine in Neurocritical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C118563', 'term': 'clevidipine'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-20', 'studyFirstSubmitDate': '2021-11-18', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effectiveness of clevidipine treatment according sex', 'timeFrame': '1 to 6 hours after clevidipine infusion beginning', 'description': 'Percentage of male and female patients with effective treatment'}, {'measure': 'Effectivennes of clevidipine treatment according medical history', 'timeFrame': '1 to 6 hours after clevidipine infusion beginning', 'description': 'Percentage of patients with history of chronic hypertension, ischemic heart disease, stroke, diabetes, hypercholesterolemia, smoking and another cardiovascular risk factor with effective treatment'}, {'measure': 'Effectivennes of clevidipine treatment according neurosurgical procedure', 'timeFrame': '1 to 6 hours after clevidipine infusion beginning', 'description': "Percentage of patients with mechanical thrombectomy, urgent craniotomy, scheduled craniotomy, urgent embolization of aneurysm causing subarachnoidal hemorrhage, urgent embolization of arterio-venous malformations, scheduled embolization of brain aneurysm, intracranial pressure monitoring sensor insertion, intraventricular fibrinolysis, deep brain stimulation for Parkinson's disease with effective treatment"}, {'measure': 'Effectivennes of clevidipine according neurocritical disease', 'timeFrame': '1 to 6 hours after clevidipine infusion beginning', 'description': 'Percentage of patients with intracerebral hemorrhage, spontaneous aneurysmal subarachnoid hemorrhage, ischemic stroke, hypertension crisis after scheduled neurosurgery and intracranial hypertension with effective treatment'}, {'measure': 'Effectivennes of clevidipine treatment according poor prognosis factors', 'timeFrame': '1 to 6 hours after clevidipine infusion beginning', 'description': 'Percentage of patients with brain hematoma volumes higher than 30 ml, National Institutes Of Health Stroke Scale (NIHSS) higher than 10 points, Fisher scale of aneurysmal subarachnoid hemorrhage of 3 or 4 points and Glasgow Coma Scale less than 8 points with effective treatment'}, {'measure': 'Effectivennes of clevidipine according functional situation', 'timeFrame': '90 days', 'description': 'Percentage of patients with modified Rankin scale between 0 to 2 points, 3 to 4 points and 5 to 6 points with effective treatment'}, {'measure': 'Incidence of adverse events according early beginning, first line and effective treatment with clevidipine', 'timeFrame': '1 hour after beginning to 24 hours after clevidipine infusion stop', 'description': 'Percentage of patients with early begin of treatment within 24 hours of admission, first line treatment choice, maintenance of goal Systolic Blood Pressure 24 hours after infusion stop and effective treatment presenting any adverse event atributed to clevididipine treatment'}, {'measure': 'Mortality according early beginning, first line and effective treatment with clevidipine', 'timeFrame': '1 to 90 days', 'description': 'Percentage of patients with early beginning of clevidipine treatment within 24 hours of admission, first line treatment, maintenance of Systolic Blood Pressure higher than 48 hours and effective treatment dead'}, {'measure': 'Major complications according early beginning, first line and effective treatment with clevidipine', 'timeFrame': '1 to 15 days', 'description': 'Percentage of patients with early beginning of clevidipine treatment within 24 hours of admission, first line treatment, maintenance of Systolic Blood Pressure higher than 48 hours and effective treatment presenting major neurological complications like rebleeding, hematoma expansion, brain swelling, intracranial hypertension, vasospasm and neurological deterioration not explained for the above'}, {'measure': 'Hematoma expansion in subgroups', 'timeFrame': '1 to 7 days', 'description': 'Percentage of patients with brain hematoma expansion presenting Systolic Blood Pressure higher than 180 mmHg, age higher than 65 years old, Glasgow Coma Scale up to 8 points at admission, chronic hypertension history, intracranial hypertension, subararchnoidal hemorrhage, intraventricular hemorrhage, hematoma volumes higher than 30 ml, spot sign, begin of treatment in first 5 hours of admission, effective treatment and clevidipine as first line.'}, {'measure': 'Vasospasm in subgroups', 'timeFrame': '1 to 15 days', 'description': 'Percentage of patients with spontaneous aneurysmal subararachnoid hemorrhage presenting vasospasm with a Systolic Blood Pressure higher than 160 mmHg, Fisher score of 3 to 4 points at admission, effective treatment and clevidipine as first line treatment.'}, {'measure': 'Aneurysm rebleeding in subgroups', 'timeFrame': '1 to 7 days', 'description': 'Percentage of patients with rebleeding after spontaneous aneurysmal subarachnoidal hemorrhage presenting Systolic Blood Pressure higher than 160 mmHg, aneurysms of posterior brain circulation, intracranial hypertension, effective treatment and first line treatment with clevidipine'}], 'primaryOutcomes': [{'measure': 'Effectiveness of clevidipine', 'timeFrame': '1 to 6 hour of clevidipine infusion beginning', 'description': 'Percentage of patients achieving target systolic blood pressure (SBP)'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events related to clevidipine treatment', 'timeFrame': '1 hour after beginning to 24 hours after clevidipine infusion stop', 'description': 'Tachycardia, atrial fibrillation, hypotension, fever, acute kidney failure, nausea, headache and facial redness.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clevidipine', 'neurocritical'], 'conditions': ['High Blood Pressure']}, 'descriptionModule': {'briefSummary': 'Acute blood pressure elevation is a frequent problem in neurocritical patients. Its effective management is challenging and must avoid significant decreases of blood pressure leading to lower cerebral perfusion pressure worsening ischemia and elevations probably associated with bleeding, rebleeding or hematoma expansion associated with poor prognosis', 'detailedDescription': 'Retrospective, observational and single-group study for observe effectiveness and safety of clevidipine for perioperative control of hypertension in patients admitted to Post-Operative Intensive Care Unit after thrombectomy for stroke, intracerebral hemorrhage requiring surgical treatment, embolization of aneurysm after subarachnoid hemorrhage, scheduled neurosurgical and neuroradiology procedures.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neurocritical patients admitted to PostOperative Intensive Care Unit after acute intracerebral hemorrhage requiring surgical treatment, mechanical thrombectomy for acute ischemic stroke, embolization of aneurysm causing subarachnoid hemorrhage and scheduled neurosurgical and neuroradiology procedures.', 'eligibilityCriteria': 'Inclusion criteria:\n\n1. -Adult patients older than 18 years old admitted to Post-Operative Intensive Care Unit with neurocritical condition requiring surgical or interventional treatment.\n2. -Acute High Blood Pressure requiring urgent treatment (SBP ≥160 mmHg or ≥ 20% increase in preoperative values that persists for more than 15 minutes)\n3. -Clevidipine used as a first line or after failure of different antihypertensive drugs.\n\nExclusion criteria:\n\n1. -Adults older than 90 years admitted to Post-Operative Intensive Care Unit with neurocritical condition requiring surgical or interventional treatment.\n2. -Patients admitted to Post-Operative Intensive Care Unit with neurocritical condition not requiring surgical or interventional treatment.'}, 'identificationModule': {'nctId': 'NCT05168059', 'acronym': 'NEURO-CLEV', 'briefTitle': 'Clevidipine in Neurocritical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Cruces'}, 'officialTitle': 'Clevidipine for Acute High Blood Pressure Control in Neurocritical Patients', 'orgStudyIdInfo': {'id': 'CEIC E19/17'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Clevidipine 0.5 MG/ML Intravenous Emulsion', 'type': 'DRUG', 'otherNames': ['CLEVIPREX'], 'description': 'Effectiveness and safety of clevidipine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48903', 'city': 'Barakaldo', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Biocruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}], 'overallOfficials': [{'name': 'Blanca Escontrela, Consultant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biocruces Bizkaia Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Database'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Cruces', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biocruces Bizkaia Health Research Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Anesthesiology and Reanimation', 'investigatorFullName': 'Blanca Escontrela', 'investigatorAffiliation': 'Hospital de Cruces'}}}}