Traumatic Brain InjuryONSD/ INHNCT07722702
ONSD Trajectory in Rebound ICH
An observational study of Traumatic Brain Injury and Rebound Intracranial Hypertension, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Traumatic Brain Injury, Rebound Intracranial Hypertension, Cerebral Edema
- What is being tested?
- Optic Nerve Sheath Diameter Ultrasonography
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Oct 2027
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Benha university hospital
Banhā, Qalyobia
Mostafa M Abdelgwad, MSC, +201002338765, sasasakr6@gmail.com
About this study
Official title: Optic Nerve Sheath Diameter Trajectory During Osmotherapy Weaning as a Predictor of Rebound Intracranial Hypertension in Traumatic Brain Injury
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.
Read more
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
Read the detailed description
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.
- Being tested
- Optic Nerve Sheath Diameter Ultrasonography
- Keywords
- ONSD, Osmotherapy, Rebound ICH, Cerebral edema
- Medical subject headings
- Brain Injuries, Traumatic, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic Nerve Sheath Diameter UltrasonographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Optic Nerve Sheath Diameter Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of rebound intracranial hypertension using serial ONSD measurements
Measured: Within 24 hours after osmotherapy reduction or discontinuation
Secondary outcomes (5)
Mortality
Death from any cause occurring during the patient's ICU stay following traumatic brain injury and during the study observation period.
Measured: From ICU admission until ICU discharge or death, assessed for up to 28 days.
2. Length of ICU Stay:
The total duration of ICU admission measured in days from ICU admission until ICU discharge or death.
Measured: From ICU admission until ICU discharge or death, assessed for up to 28 days.
Need for rescue ICP therapy:
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
Measured: Within 48 hours after osmotherapy weaning.
Glasgow Coma Scale trajectory post-weaning
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.
Measured: 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
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.
Measured: Assessed continuously during the first 48 hours after osmotherapy weaning. For patients who do not develop rebound, time will be censored at 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722702
- Sponsor's protocol ID
- MD_6.5.2026
- Acronym
- ONSD/ INH
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Nerve Sheath Diameter Trajectory During Osmotherapy Weaning as a Predictor of Rebound Intracranial Hypertension in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07722702
- Acronym / sponsor ID
- ONSD/ INH / MD_6.5.2026
- Keywords
- ONSD, Osmotherapy, Rebound ICH, Cerebral edema
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic Brain Injury Patients Undergoing Osmotherapy Weaning | – | Diagnostic Test: Optic Nerve Sheath Diameter UltrasonographyAdult 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic Nerve Sheath Diameter UltrasonographySerial 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. | Diagnostic test | Traumatic Brain Injury Patients Undergoing Osmotherapy Weaning |
Primary outcome
Prediction of rebound intracranial hypertension using serial ONSD measurements
Time frame: Within 24 hours after osmotherapy reduction or discontinuation
5 secondary outcomes
Mortality
Time frame: From ICU admission until ICU discharge or death, assessed for up to 28 days.
2. Length of ICU Stay:
Time frame: From ICU admission until ICU discharge or death, assessed for up to 28 days.
Need for rescue ICP therapy:
Time frame: Within 48 hours after osmotherapy weaning.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Rebound Intracranial Hypertension, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Mohamed Sakr, Critical care MSC (+201002338765 ext. +201069610038, sasasakr6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of rebound intracranial hypertension using serial ONSD measurements (time frame: Within 24 hours after osmotherapy reduction or discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.