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ONSD Trajectory in Rebound ICH (ONSD/ INH)

19 luglio 2026 aggiornato da: Mostafa Mohamed, Benha University

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.

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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Mostafa Mohamed Sakr, Critical care MSC
  • Numero di telefono: +201069610038 +201002338765
  • Email: sasasakr6@gmail.com

Luoghi di studio

  • Egitto
    • Qalyobia
      • Banhā, Qalyobia, Egitto
        • Benha university hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Test diagnostico: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Prediction of rebound intracranial hypertension using serial ONSD measurements
Lasso di tempo: Within 24 hours after osmotherapy reduction or discontinuation
Within 24 hours after osmotherapy reduction or discontinuation

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mortality
Lasso di tempo: 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.
From ICU admission until ICU discharge or death, assessed for up to 28 days.
2. Length of ICU Stay:
Lasso di tempo: 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.
From ICU admission until ICU discharge or death, assessed for up to 28 days.
Need for rescue ICP therapy:
Lasso di tempo: 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
Within 48 hours after osmotherapy weaning.
Glasgow Coma Scale trajectory post-weaning
Lasso di tempo: 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.
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
Lasso di tempo: 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.
Assessed continuously during the first 48 hours after osmotherapy weaning. For patients who do not develop rebound, time will be censored at 48 hours.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Benha University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 ottobre 2027

Date di iscrizione allo studio

Primo inviato

10 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MD_6.5.2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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