Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
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)
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
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
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
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