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Clinical Trials/NCT06286696
NCT06286696
Not yet recruiting
Not Applicable

Point-of-care Ultrasound of Optic Nerve Sheath Diameter in Suspected Hypertensive Emergency

Leiden University Medical Center0 sites375 target enrollmentNovember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertensive Emergency
Sponsor
Leiden University Medical Center
Enrollment
375
Primary Endpoint
Papilledema
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
December 1, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Leiden University Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Tessa Mulder

Principal Investigator

Leiden University Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Papilledema

Time Frame: 2 years

Sensitivity of ONSD \> 5mm for diagnosis of papilledema

Secondary Outcomes

  • Hypertensive encephalopathy(2 years)
  • Hypertensive retinopathy grade 3 & 4 combined(2 years)
  • Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve(2 years)
  • Rapid acting medications administered intravenously to lower the elevated blood pressure(2 years)

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