An observational study in High Blood Pressure, sponsored by Hospital de Cruces. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2021-12-23.
Sponsored by Hospital de Cruces · Observational
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
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 33 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Hospital de Cruces is the lead sponsor of 9 studies on the registry; none are open to participants now.
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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.
Exclusion criteria:
Effectiveness and safety of clevidipine
Also known as: CLEVIPREX
Effectiveness of clevidipine
Percentage of patients achieving target systolic blood pressure (SBP)
Time frame: 1 to 6 hour of clevidipine infusion beginning
Incidence of adverse events related to clevidipine treatment
Tachycardia, atrial fibrillation, hypotension, fever, acute kidney failure, nausea, headache and facial redness.
Time frame: 1 hour after beginning to 24 hours after clevidipine infusion stop
Effectiveness of clevidipine treatment according sex
Percentage of male and female patients with effective treatment
Time frame: 1 to 6 hours after clevidipine infusion beginning
Effectivennes of clevidipine treatment according medical history
Percentage of patients with history of chronic hypertension, ischemic heart disease, stroke, diabetes, hypercholesterolemia, smoking and another cardiovascular risk factor with effective treatment
Time frame: 1 to 6 hours after clevidipine infusion beginning
Effectivennes of clevidipine treatment according neurosurgical procedure
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
Time frame: 1 to 6 hours after clevidipine infusion beginning
Effectivennes of clevidipine according neurocritical disease
Percentage of patients with intracerebral hemorrhage, spontaneous aneurysmal subarachnoid hemorrhage, ischemic stroke, hypertension crisis after scheduled neurosurgery and intracranial hypertension with effective treatment
Time frame: 1 to 6 hours after clevidipine infusion beginning
Effectivennes of clevidipine treatment according poor prognosis factors
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
Time frame: 1 to 6 hours after clevidipine infusion beginning
Effectivennes of clevidipine according functional situation
Percentage of patients with modified Rankin scale between 0 to 2 points, 3 to 4 points and 5 to 6 points with effective treatment
Time frame: 90 days
Incidence of adverse events according early beginning, first line and effective treatment with clevidipine
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
Time frame: 1 hour after beginning to 24 hours after clevidipine infusion stop
Mortality according early beginning, first line and effective treatment with clevidipine
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
Time frame: 1 to 90 days
Major complications according early beginning, first line and effective treatment with clevidipine
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
Time frame: 1 to 15 days
Hematoma expansion in subgroups
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.
Time frame: 1 to 7 days
Vasospasm in subgroups
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.
Time frame: 1 to 15 days
Aneurysm rebleeding in subgroups
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
Time frame: 1 to 7 days
Plan to share: Undecided — Database
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Hospital de Cruces