High Blood PressureNEURO-CLEVNCT05168059
Clevidipine in Neurocritical Patients
An observational study of High Blood Pressure, run by Hospital de Cruces at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Clevidipine 0.5 MG/ML Intravenous Emulsion
- Type of treatment
- Injection or infusion
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2017to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
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.
Who may be able to join
- -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.
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- High Blood Pressure
- Being tested
- Clevidipine 0.5 MG/ML Intravenous Emulsion
- Keywords
- clevidipine, neurocritical
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clevidipine 0.5 MG/ML Intravenous EmulsionDrug
Also called CLEVIPREX
Effectiveness and safety of clevidipine
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of clevidipine
Percentage of patients achieving target systolic blood pressure (SBP)
Measured: 1 to 6 hour of clevidipine infusion beginning
Secondary outcomes (1)
Incidence of adverse events related to clevidipine treatment
Tachycardia, atrial fibrillation, hypotension, fever, acute kidney failure, nausea, headache and facial redness.
Measured: 1 hour after beginning to 24 hours after clevidipine infusion stop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2018
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Cruces
- Sponsor type
- University, hospital or other
- Collaborators
- Biobizkaia Health Research Institute
- Responsible party
- Principal investigator, Blanca Escontrela, Hospital de Cruces
- Investigators
- Blanca Escontrela, Consultant, Principal investigator, Biobizkaia Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168059
- Sponsor's protocol ID
- CEIC E19/17
- Acronym
- NEURO-CLEV
- Status last verified
- Dec 2021
- First submitted
- 18 Nov 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Database
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clevidipine for Acute High Blood Pressure Control in Neurocritical Patients
- ClinicalTrials.gov ID
- NCT05168059
- Acronym / sponsor ID
- NEURO-CLEV / CEIC E19/17
- Conditions
- High Blood Pressure
- Keywords
- clevidipine, neurocritical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospital de CrucesUniversity, hospital or other
- Collaborators
- Biobizkaia Health Research Institute
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- -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.
Key exclusion criteria (2 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clevidipine 0.5 MG/ML Intravenous EmulsionAlso: CLEVIPREXEffectiveness and safety of clevidipine | Drug | – |
Primary outcome
Effectiveness of clevidipine
Time frame: 1 to 6 hour of clevidipine infusion beginning
Percentage of patients achieving target systolic blood pressure (SBP)
1 secondary outcome
Incidence of adverse events related to clevidipine treatment
Time frame: 1 hour after beginning to 24 hours after clevidipine infusion stop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Individual participant dataSharing planned: Undecided. Database
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blanca Escontrela, Consultant principal investigator
Biobizkaia Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Blood Pressure, run by Hospital de Cruces at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of clevidipine (time frame: 1 to 6 hour of clevidipine infusion beginning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.