Clinical trial NCT05168059: Clevidipine in Neurocritical Patients
Official title: Clevidipine for Acute High Blood Pressure Control in Neurocritical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Blood Pressure
Keywords: clevidipine
neurocritical
Lead sponsor: Hospital de Cruces
Sponsor class: OTHER
Collaborators: name: Biocruces Bizkaia Health Research Institute
First posted: 2021-12-23
Enrollment: 33
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

1. -Adult patients older than 18 years old admitted to Post-Operative Intensive Care Unit with neurocritical condition requiring surgical or interventional treatment.
2. -Acute High Blood Pressure requiring urgent treatment (SBP ≥160 mmHg or ≥ 20% increase in preoperative values that persists for more than 15 minutes)
3. -Clevidipine used as a first line or after failure of different antihypertensive drugs.

Exclusion criteria:

1. -Adults older than 90 years admitted to Post-Operative Intensive Care Unit with neurocritical condition requiring surgical or interventional treatment.
2. -Patients admitted to Post-Operative Intensive Care Unit with neurocritical condition not requiring surgical or interventional treatment.

Primary outcomes:
measure: Effectiveness of clevidipine
timeFrame: 1 to 6 hour of clevidipine infusion beginning
Secondary outcomes:
measure: Incidence of adverse events related to clevidipine treatment
timeFrame: 1 hour after beginning to 24 hours after clevidipine infusion stop
Other outcomes:
measure: Effectiveness of clevidipine treatment according sex
timeFrame: 1 to 6 hours after clevidipine infusion beginning
measure: Effectivennes of clevidipine treatment according medical history
timeFrame: 1 to 6 hours after clevidipine infusion beginning
measure: Effectivennes of clevidipine treatment according neurosurgical procedure
timeFrame: 1 to 6 hours after clevidipine infusion beginning
measure: Effectivennes of clevidipine according neurocritical disease
timeFrame: 1 to 6 hours after clevidipine infusion beginning
measure: Effectivennes of clevidipine treatment according poor prognosis factors
timeFrame: 1 to 6 hours after clevidipine infusion beginning
measure: Effectivennes of clevidipine according functional situation
timeFrame: 90 days
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
measure: Mortality according early beginning, first line and effective treatment with clevidipine
timeFrame: 1 to 90 days
measure: Major complications according early beginning, first line and effective treatment with clevidipine
timeFrame: 1 to 15 days
measure: Hematoma expansion in subgroups
timeFrame: 1 to 7 days
measure: Vasospasm in subgroups
timeFrame: 1 to 15 days
measure: Aneurysm rebleeding in subgroups
timeFrame: 1 to 7 days
Locations:
city: Barakaldo
country: Spain
facility: Biocruces
state: Vizcaya
Study officials:
affiliation: Biocruces Bizkaia Health Research Institute
name: Blanca Escontrela, Consultant
role: PRINCIPAL_INVESTIGATOR
References: