Hypertensive EmergencyOpticUSNCT06286696
Optic Nerve Sheath Diameter in Hypertensive Emergency
An observational study of Hypertensive Emergency and Papilledema, run by Leiden University Medical Center.
Trial summary
This prospective observational study investigates the potential of point-of-care ultrasonography of the optic nerve sheath diameter (ONSD) to rule out papilledema in patients with suspected hypertensive emergency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertensive Emergency, Papilledema, Hypertension
- What is being tested?
- Optic Nerve Sheath Diameter
- How many people
- 375 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the emergency department with suspected hypertensive emergency.
Who may be able to join
- ≥ 18 years old
- Any patient presenting to the emergency department (ED) with suspected hypertensive emergency i.e.: blood pressure of > 200 millimetres of mercury (mmHg) systolic and/or > 120 mmHg diastolic
Who cannot join
- Patients with preexisting optic nerve head changes such as glaucoma, pre-existing retinal artery/vein occlusions or any other condition that makes assessment of the fundi impossible.
- Primary neurological cause of hypertension: ischemic cerebrovascular incident
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Point-of-care Ultrasound of Optic Nerve Sheath Diameter in Suspected Hypertensive Emergency
This prospective observational study investigates the potential of point-of-care ultrasonography of the optic nerve sheath diameter (ONSD) to rule out papilledema in patients with suspected hypertensive emergency. The primary focus is on assessing ONSD sensitivity in identifying papilledema (hypertensive retinopathy grade 4), while secondary endpoints include hypertensive retinopathy grade 3, hypertensive encephalopathy, and the need for intravenous rapid-acting medications to lower elevated blood pressure. This study aims to determine the diagnostic characteristics of this procedure for the diagnosis of hypertensive retinopathy, thus assessing its potential as a screening tool to rule out hypertensive retinopathy by the acute internal medicine doctor.
- Conditions
- Hypertensive Emergency, Papilledema, Hypertension
- Being tested
- Optic Nerve Sheath Diameter
- Medical subject headings
- Hypertensive Crisis, Papilledema, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic Nerve Sheath DiameterDiagnostic test
Point of care ultrasonography of the optic nerve sheath diameter
What is being measured
The primary outcome is the main question the study is designed to answer.
Papilledema
Sensitivity of ONSD > 5mm for diagnosis of papilledema
Measured: 2 years
Secondary outcomes (4)
Hypertensive retinopathy grade 3 & 4 combined
Sensitivity/specificity of the ONSD for hypertensive retinopathy grade 3 \& 4 combined
Measured: 2 years
Hypertensive encephalopathy
Sensitivity/specificity of the ONSD for hypertensive encephalopathy
Measured: 2 years
Rapid acting medications administered intravenously to lower the elevated blood pressure
Sensitivity/specificity of the ONSD for the need for rapid acting medications administered intravenously to lower the elevated blood pressure
Measured: 2 years
Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve
Diagnostic characteristics for the presence of a bulging optic nerve disc and/or crescent sign for above mentioned diagnoses (papilledema, hypertensive retinopathy grade 3\&4 combined, hypertensive encephalopathy, need for rapid acting intravenous medications to lower elevated bloodpressure).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive EmergencyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tessa Mulder, Leiden University Medical Center
- Investigators
- Tessa Mulder, MD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286696
- Sponsor's protocol ID
- NL84914.058.23
- Acronym
- OpticUS
- Status last verified
- Oct 2024
- First submitted
- 30 Jan 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Ultrasound of Optic Nerve Sheath Diameter in Suspected Hypertensive Emergency
- ClinicalTrials.gov ID
- NCT06286696
- Acronym / sponsor ID
- OpticUS / NL84914.058.23
- Conditions
- Hypertensive Emergency, Papilledema, Hypertension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Feb 2024 (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.
This prospective observational study investigates the potential of point-of-care ultrasonography of the optic nerve sheath diameter (ONSD) to rule out papilledema in patients with suspected hypertensive emergency. The primary focus is on assessing ONSD sensitivity in identifying papilledema (hypertensive retinopathy grade 4), while secondary endpoints include hypertensive retinopathy grade 3, hypertensive encephalopathy, and the need for intravenous rapid-acting medications to lower elevated blood pressure. This study aims to determine the diagnostic characteristics of this procedure for the diagnosis of hypertensive retinopathy, thus assessing its potential as a screening tool to rule out hypertensive retinopathy by the acute internal medicine doctor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the emergency department with suspected hypertensive emergency.
Key inclusion criteria (2 listed)
- ≥ 18 years old
- Any patient presenting to the emergency department (ED) with suspected hypertensive emergency i.e.: blood pressure of > 200 millimetres of mercury (mmHg) systolic and/or > 120 mmHg diastolic
Key exclusion criteria (2 listed)
- Patients with preexisting optic nerve head changes such as glaucoma, pre-existing retinal artery/vein occlusions or any other condition that makes assessment of the fundi impossible.
- Primary neurological cause of hypertension: ischemic cerebrovascular incident
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 |
|---|---|---|
| Optic Nerve Sheath DiameterPoint of care ultrasonography of the optic nerve sheath diameter | Diagnostic test | – |
Primary outcome
Papilledema
Time frame: 2 years
Sensitivity of ONSD > 5mm for diagnosis of papilledema
4 secondary outcomes
Hypertensive retinopathy grade 3 & 4 combined
Time frame: 2 years
Hypertensive encephalopathy
Time frame: 2 years
Rapid acting medications administered intravenously to lower the elevated blood pressure
Time frame: 2 years
Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Tessa Mulder, MD principal investigator
Leiden University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Emergency and Papilledema, run by Leiden University Medical Center.
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 2 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: opening soon, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tessa Mulder, MD (+31 71 52 96151, t.a.mulder@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Papilledema (time frame: 2 years). 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 9 Oct 2024.