Actively Recruiting

Age: 18Years - 60Years
All Genders
ID07332234

Utility of Optic Nerve Ultrasonography in Assessing Cerebral Inflammation and Intracranial Hypertension in Patients With Cerebral Impairment

Led by Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș" · Updated on 2026-01-12

200

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"

Lead Sponsor

I

Institutul Clinic Fundeni

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of optic nerve ultrasound to detect signs of raised intracranial pressure and persistent inflammation in patients with brain damage. This observational study focuses on patients admitted with suspected meningitis, encephalitis, stroke, or cerebral tumors. The goal is to assess how well optic nerve ultrasound can estimate cerebral inflammation and cerebral edema, which may help speed up treatment decisions and improve patient outcomes. The study involves two groups: one with infectious brain conditions like meningitis or encephalitis, and another with non-infectious neurological conditions such as stroke or brain tumors. Participants will undergo daily assessments including optic nerve ultrasound to measure the optic nerve sheath diameter, consciousness evaluations using validated scales, and transcranial Doppler to assess brain blood flow. Additional tests include CT scans, lumbar punctures to measure cerebrospinal fluid pressure, and blood sampling for inflammation markers. These procedures will be conducted daily or at specific intervals during the first week of hospitalization. Participants will be closely monitored with daily clinical evaluations and imaging over the first seven days of hospital stay. Data collected will include optic nerve sheath diameter, consciousness scores, cerebral blood flow indices, and laboratory markers of inflammation and neuronal injury. The study will also review 28-day mortality, quality of life, and complication rates. Consent procedures account for patients who may lack capacity initially, with consent obtained from legal representatives and later directly from patients when possible. The study is expected to complete by December 2027 with about 200 participants.

CONDITIONS

Brief Title

Optic Nerve Ultrasound for Assessing Cerebral Inflammation and Intracranial Hypertension in Cerebral Pathologies

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients admitted into one of the specified wards of the involved hospitals
  • Patients aged 18-60 years
  • Suspected meningitis, encephalitis, stroke or cerebral tumors
Not Eligible

You will not qualify if you...

  • Age under 18 years or over 60 years old
  • Ocular lesions preventing ocular ultrasound (palpebral infections, cornean erosions, glaucoma, trauma)
  • Conditions preventing lumbar puncture (coagulation disorders, epidural abscesses, local infections)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - Up to 48 hours after hospital admission

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Monitoring

Duration - Up to 7 days during hospitalization

Participants undergo daily assessments including optic nerve ultrasound, consciousness scales, and blood sampling during hospitalization to evaluate cerebral inflammation and intracranial pressure.

Daily visits (in-person) for up to 7 days

Follow-up

Duration - 28 days after admission

Participants are monitored for clinical outcomes including mortality, quality of life, and complications up to 28 days after admission.

1 follow-up visit (in-person or remote) around day 28

Trial Site Locations

Total: 2 locations

1

Fundeni Clinical Institute

Bucharest, Bucharest, Romania, 022315

Actively Recruiting

2

"Dr. Victor Babeș" Clinical Hospital for Infectious and Tropical Diseases

Bucharest, Bucharest, Romania, 030303

Actively Recruiting

Loading map...

Research Team

B

Bogdan Pavel, MD, PhD, DESA

S

Sebastian Isac, MD, PhD, DESA

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Similar Trials

3D Contrast Enhanced Microvascular Ultrasound of Carotid Ath...

Carotid Atherosclerosis

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here