ONSD Trajectory in Rebound ICH

NCT07722702 · tracked via the Priya Life Science Egypt tracker

Sponsor

Benha University

Phase

Observational

Started

2026-09-01

Last updated

2026-07-23

Condition(s) studied

Traumatic Brain InjuryRebound Intracranial HypertensionCerebral Edema

Investigational drug(s) / intervention(s)

Optic Nerve Sheath Diameter Ultrasonography

Optic Nerve Sheath Diameter Ultrasonography: Serial ultrasonographic measurement of optic nerve sheath diameter (ONSD) will be performed bilaterally using a standardized transorbital ultrasound technique immediately before osmotherapy reduction or discontinuation (baseline) and at 4, 6, 12, and 24 hours after weaning. Additional measurements may be obtained if clinical deterioration suggestive of rebound intracranial hypertension occurs. ONSD measurements are performed for observational purposes only and will not influence routine clinical management.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

Prediction of rebound intracranial hypertension using serial ONSD measurements — Within 24 hours after osmotherapy reduction or discontinuation

Trial sites (1)

Facility	City	Region	Status
Benha university hospital	Banhā	Qalyobia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07722702 on ClinicalTrials.gov ↗ ← All trials in Egypt