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NCT Number: NCT07722702

ONSD Trajectory in Rebound ICH

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Traumatic brain injury (TBI) is a major cause of morbidity and mortality worldwide. Cerebral edema and elevated intracranial pressure (ICP) are common secondary complications that require prompt management to prevent further neurological injury. Osmotherapy with hypertonic saline or mannitol is routinely used to reduce ICP; however, withdrawal or weaning of osmotherapy may be associated with rebound intracranial hypertension, which can worsen neurological outcomes if not recognized early.

Optic nerve sheath diameter (ONSD), measured by bedside ocular ultrasonography, is a non-invasive surrogate marker of raised intracranial pressure. Although ONSD has been shown to correlate with ICP in several clinical settings, the predictive value of serial ONSD measurements during osmotherapy weaning for identifying rebound intracranial hypertension has not been adequately investigated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optic Nerve Sheath Diameter Ultrasonography

Diagnostic Test

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.

Primary outcomes

  1. Prediction of rebound intracranial hypertension using serial ONSD measurements

    Time frame: Within 24 hours after osmotherapy reduction or discontinuation

Secondary outcomes

  1. Mortality

    Time frame: From ICU admission until ICU discharge or death, assessed for up to 28 days.

    Death from any cause occurring during the patient's ICU stay following traumatic brain injury and during the study observation period.

  2. 2. Length of ICU Stay:

    Time frame: From ICU admission until ICU discharge or death, assessed for up to 28 days.

    The total duration of ICU admission measured in days from ICU admission until ICU discharge or death.

  3. Need for rescue ICP therapy:

    Time frame: Within 48 hours after osmotherapy weaning.

    Requirement for additional ICP-lowering interventions beyond restarting osmotherapy due to suspected or confirmed rebound intracranial hypertension. Rescue therapies include: (a) barbiturate infusion (thiopental or pentobarbital), (b) therapeutic hypothermia (target temperature ≤35°C), or (c) controlled hyperventilation (PaCO₂ <30 mmH

  4. Glasgow Coma Scale trajectory post-weaning

    Time frame: Measured at baseline (immediately before osmotherapy weaning), then at 4, 6, 12, and 24 hours after weaning (aligned with ONSD measurement time points). The primary analysis will use change in GCS from baseline to 24 hours as a continuous variable.

    Neurological status assessed using the Glasgow Coma Scale (GCS). The GCS total score ranges from 3 to 15, with higher scores indicating better neurological function. A decrease of ≥2 points from the baseline GCS score after osmotherapy discontinuation is considered neurological deterioration suggestive of rebound intracranial hypertension.

  5. Time to rebound intracranial hypertension

    Time frame: Assessed continuously during the first 48 hours after osmotherapy weaning. For patients who do not develop rebound, time will be censored at 48 hours.

    The interval (in hours) from complete osmotherapy discontinuation (T0) to the first documented episode of rebound intracranial hypertension. Rebound is identified by either: (a) decline in GCS of ≥2 points from baseline not attributable to other causes, or (b) worsening on brain imaging showing increased cerebral edema or mass effect.

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa Mohamed Sakr, Critical care MSC

CONTACT

[email protected]

+201002338765 ext. +201069610038

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Optic Nerve Sheath Diameter Trajectory During Osmotherapy Weaning as a Predictor of Rebound Intracranial Hypertension in Traumatic Brain Injury

Acronym: ONSD/ INH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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