ONSD Trajectory in Rebound ICH

NCT07722702 | Not Yet Recruiting

• 1 other identifier: MD_6.5.2026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Traumatic Brain Injury; Rebound Intracranial Hypertension; Cerebral Edema

Keywords

ONSD; Osmotherapy; Rebound ICH; Cerebral edema

Outcome Measures

Primary Outcomes (1)

• Prediction of rebound intracranial hypertension using serial ONSD measurements

  Within 24 hours after osmotherapy reduction or discontinuation

Secondary Outcomes (5)

• Mortality

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

• 2. Length of ICU Stay:

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

• Need for rescue ICP therapy:

  Within 48 hours after osmotherapy weaning.

• Glasgow Coma Scale trajectory post-weaning

  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.

• Time to rebound intracranial hypertension

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

Study Arms (1)

Traumatic Brain Injury Patients Undergoing Osmotherapy Weaning

Adult patients with traumatic brain injury receiving osmotherapy for intracranial hypertension who undergo protocol-defined osmotherapy weaning. Participants will undergo serial optic nerve sheath diameter (ONSD) measurements before and after osmotherapy reduction or discontinuation and will be followed prospectively for the development of rebound intracranial hypertension and related clinical outcomes.

Diagnostic Test: Optic Nerve Sheath Diameter Ultrasonography

Interventions

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.

Traumatic Brain Injury Patients Undergoing Osmotherapy Weaning

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with traumatic brain injury admitted to the intensive care unit who require osmotherapy for cerebral edema management. Eligible patients will undergo serial optic nerve sheath diameter measurements and computed tomography evaluation according to the study protocol.

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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university hospital

Banhā, Qalyobia, Egypt

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Edema

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Mostafa Mohamed Sakr, Critical care MSC

CONTACT

+201002338765; sasasakr6@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Critical care assistant lecturer

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)