Optic Nerve Sheath Diameter in Hypertensive Emergency

NCT ID: NCT06286696

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

375 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertensive Emergency Papilledema Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Optic Nerve Sheath Diameter

Point of care ultrasonography of the optic nerve sheath diameter

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* ≥ 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tessa Mulder

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tessa Mulder, MD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Central Contacts

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Tessa Mulder, MD

Role: CONTACT

+31 71 52 96151

Martijn Bauer, MD, PhD

Role: CONTACT

+31 71 52 62381

Other Identifiers

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NL84914.058.23

Identifier Type: -

Identifier Source: org_study_id

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