NCT07722702Not yet recruiting
ONSD Trajectory in Rebound ICH
Optic Nerve Sheath Diameter Trajectory During Osmotherapy Weaning as a Predictor of Rebound Intracranial Hypertension in Traumatic Brain Injury
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
The goal of this prospective observational study is to determine whether the trajectory of optic nerve sheath diameter (ONSD) after osmotherapy weaning can predict rebound intracranial hypertension in adult patients with traumatic brain injury requiring osmotherapy for elevated intracranial pressure. The main questions it aims to answer are: Does the trajectory of ONSD during osmotherapy weaning predict the development of rebound intracranial hypertension? What is the diagnostic accuracy of serial ONSD measurements for the early detection of rebound intracranial hypertension? Researchers will compare patients who develop rebound intracranial hypertension with those who do not to determine whether changes in ONSD trajectory differ significantly between the two groups. Participants will: Undergo serial bedside ocular ultrasound examinations for ONSD measurement at predefined time points after osmotherapy weaning. Receive standard clinical management for traumatic brain injury according to institutional protocols; no additional therapeutic intervention will be administered. Undergo routine neurological assessments, laboratory investigations, and neuroimaging as clinically indicated. Be followed for the occurrence of rebound intracranial hypertension and relevant clinical outcomes during their ICU stay
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 10 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Benha University
- Diseases
- High blood pressure
- NCT number
- NCT07722702
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Sept 2026 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ocular conditions precluding ONSD measurement (glaucoma, prior ocular surgery,
Lab values
- planned decompressive surgery or evacuation of mass lesion within 48 hours; limitation of life-sustaining therapy; pregnancy; contraindications to mannitol (baseline sodium \>155 mEq/L, osmolality \>320 mOsm/kg, eGFR \<30 mL/min); penetrating TBI; or concurrent spinal cord injury with shock.
Other
- globe or optic nerve trauma,
- periorbital edema, orbital masses, optic nerve sheath cysts);
Who the study is looking for
- Adults (≥18 years) with blunt traumatic brain injury admission GCS ≤12
- (or GCS 13-15 with CT signs of elevated ICP including midline shift ≥5 mm, effaced cisterns, or significant cerebral edema)
- clinical decision to initiate 20% mannitol osmotherapy
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Benha University Hospital Coordinator of this site? Confirm its status | Banhā | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.