ONSD Trajectory in Rebound ICH
Starting soon
Conditions studied: Traumatic Brain Injury, Rebound Intracranial Hypertension, Cerebral Edema
In brief
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
Key facts
- Study ID
- NCT07722702
- Run by
- Benha University
- People needed
- 100
- Starts
- 2026-09-01
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Ocular conditions precluding ONSD measurement (glaucoma, prior ocular surgery,
- globe or optic nerve trauma,
- periorbital edema, orbital masses, optic nerve sheath cysts);
- 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.
Where it is running
- Benha university hospital — Banhā, Qalyobia, Egypt
Full record on ClinicalTrials.gov
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