ONSD Trajectory in Rebound ICH
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBenha University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Optic Nerve Sheath Diameter Ultrasonography
Diagnostic testSerial 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Traumatic Brain Injury Patients Undergoing Osmotherapy Weaning1 intervention
Trial outcomes
Primary outcomes
1
Prediction of rebound intracranial hypertension using serial ONSD measurements
Time frame
Within 24 hours after osmotherapy reduction or discontinuationSecondary outcomes
1
Mortality
Death from any cause occurring during the patient's ICU stay following traumatic brain injury and during the study observation period.
Time frame
From ICU admission until ICU discharge or death, assessed for up to 28 days.2
2. Length of ICU Stay:
The total duration of ICU admission measured in days from ICU admission until ICU discharge or death.
Time frame
From ICU admission until ICU discharge or death, assessed for up to 28 days.3
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
Time frame
Within 48 hours after osmotherapy weaning.4
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: