Clevidipine in Neurocritical Patients (NEURO-CLEV)

Clevidipine for Acute High Blood Pressure Control 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

Study Overview

• Status: Completed
• Conditions: High Blood Pressure
• Intervention / Treatment: Drug: Clevidipine 0.5 MG/ML Intravenous Emulsion

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.

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Spain
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • Biocruces

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of clevidipine	Percentage of patients achieving target systolic blood pressure (SBP)	1 to 6 hour of clevidipine infusion beginning

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events related to clevidipine treatment	Tachycardia, atrial fibrillation, hypotension, fever, acute kidney failure, nausea, headache and facial redness.	1 hour after beginning to 24 hours after clevidipine infusion stop

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of clevidipine treatment according sex	Percentage of male and female patients with effective treatment	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	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	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	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	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	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	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	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	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.	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.	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	1 to 7 days

Collaborators and Investigators

• Sponsor: Hospital de Cruces
• Collaborators: Biocruces Bizkaia Health Research Institute
• Investigators: Principal Investigator: Blanca Escontrela, Consultant, Biocruces Bizkaia Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: clevidipine; neurocritical
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Clevidipine
• Other Study ID Numbers: CEIC E19/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Database

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No