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Completed

NCT Number: NCT05168059

Clevidipine in Neurocritical Patients

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

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Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Study type

Observational

Primary location

Biocruces

Barakaldo, Vizcaya, 48903, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Clevidipine 0.5 MG/ML Intravenous Emulsion

Drug

Effectiveness and safety of clevidipine

Other names: CLEVIPREX

Primary outcomes

  1. Effectiveness of clevidipine

    Time frame: 1 to 6 hour of clevidipine infusion beginning

    Percentage of patients achieving target systolic blood pressure (SBP)

Secondary outcomes

  1. Incidence of adverse events related to clevidipine treatment

    Time frame: 1 hour after beginning to 24 hours after clevidipine infusion stop

    Tachycardia, atrial fibrillation, hypotension, fever, acute kidney failure, nausea, headache and facial redness.

Other outcomes

  1. Effectiveness of clevidipine treatment according sex

    Time frame: 1 to 6 hours after clevidipine infusion beginning

    Percentage of male and female patients with effective treatment

  2. Effectivennes of clevidipine treatment according medical history

    Time frame: 1 to 6 hours after clevidipine infusion beginning

    Percentage of patients with history of chronic hypertension, ischemic heart disease, stroke, diabetes, hypercholesterolemia, smoking and another cardiovascular risk factor with effective treatment

  3. Effectivennes of clevidipine treatment according neurosurgical procedure

    Time frame: 1 to 6 hours after clevidipine infusion beginning

    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

  4. Effectivennes of clevidipine according neurocritical disease

    Time frame: 1 to 6 hours after clevidipine infusion beginning

    Percentage of patients with intracerebral hemorrhage, spontaneous aneurysmal subarachnoid hemorrhage, ischemic stroke, hypertension crisis after scheduled neurosurgery and intracranial hypertension with effective treatment

  5. Effectivennes of clevidipine treatment according poor prognosis factors

    Time frame: 1 to 6 hours after clevidipine infusion beginning

    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

  6. Effectivennes of clevidipine according functional situation

    Time frame: 90 days

    Percentage of patients with modified Rankin scale between 0 to 2 points, 3 to 4 points and 5 to 6 points with effective treatment

  7. Incidence of adverse events according early beginning, first line and effective treatment with clevidipine

    Time frame: 1 hour after beginning to 24 hours after clevidipine infusion stop

    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

  8. Mortality according early beginning, first line and effective treatment with clevidipine

    Time frame: 1 to 90 days

    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

  9. Major complications according early beginning, first line and effective treatment with clevidipine

    Time frame: 1 to 15 days

    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

  10. Hematoma expansion in subgroups

    Time frame: 1 to 7 days

    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.

  11. Vasospasm in subgroups

    Time frame: 1 to 15 days

    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.

  12. Aneurysm rebleeding in subgroups

    Time frame: 1 to 7 days

    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

Sponsors and collaborators

Lead sponsor

Hospital de Cruces

Other

Collaborators

  • Biobizkaia Health Research Institute

Registry information

Official study title

Clevidipine for Acute High Blood Pressure Control in Neurocritical Patients

Acronym: NEURO-CLEV

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Dec 23, 2021
Registry last updated
Dec 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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