Optic Nerve Sheath Diameter in Hypertensive Emergency

NCT06286696 | Not Yet Recruiting DMC

• 1 other identifier: NL84914.058.23
• Study Type: observational
• Target: 375
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Papilledema

  Sensitivity of ONSD \> 5mm for diagnosis of papilledema

  2 years

Secondary Outcomes (4)

• Hypertensive retinopathy grade 3 & 4 combined

  2 years

• Hypertensive encephalopathy

  2 years

• Rapid acting medications administered intravenously to lower the elevated blood pressure

  2 years

• Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve

  2 years

Interventions

Optic Nerve Sheath Diameter DIAGNOSTIC_TEST

Point of care ultrasonography of the optic nerve sheath diameter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the emergency department with suspected hypertensive emergency.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead

MeSH Terms

Conditions

Hypertensive Crisis; Papilledema; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Tessa Mulder, MD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tessa Mulder, MD

CONTACT

+31 71 52 96151; t.a.mulder@lumc.nl

Martijn Bauer, MD, PhD

CONTACT

+31 71 52 62381; m.p.bauer@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 29, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10