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TBI (Traumatic Brain Injury)MHTS-ONSDNCT07786324

Comparison of Hyperosmolar Agent in Reduction of Increased Intracranial Pressure in Patients With Traumatic Brain Injury Using Ultrasonography

A study testing Mannitol (20%) and Hypertonic Saline ( 3% Sodium Chloride Saline) in people with TBI (Traumatic Brain Injury) and ICP (Intracranial Pressure) Increase, run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of this study to compare the efficacy of hypertonic saline and mannitol in reducing intracranial pressure, as assessed by serial optic nerve sheath diameter (ONSD) ultrasound measurements, in patients with traumatic brain injury. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mannitol (20%) and Hypertonic Saline ( 3% Sodium Chloride Saline)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Oct 2026to 30 Sep 2029
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • Age ≥18 years.
  • Acute severe traumatic brain injury (TBI) (GCS 3-8) confirmed by CT brain.
  • Elevated ONSD suggestive of raised ICP (ONSD cutoff value ≥5.6 mm ).(14)
  • Initiation of hyperosmolar therapy within 24 hours of injury.

Who cannot join

  • • Penetrating head injury.
  • Hypotension.
  • Previous ocular trauma or orbital surgery.
  • Glaucoma or optic nerve pathology.
  • Bilateral ocular injuries preventing ultrasound assessment.
  • Pregnancy.
Show all 10Show fewer
  • Chronic renal failure requiring dialysis.
  • Initial serum sodium >150mmol/L or Patients reaching a sodium level >160mmol/L during hypertonic administration.
  • Previous hyperosmolar therapy before enrollment.
  • Refusal of consent by legal surrogate.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mostafa Hassan Abdellah, assisstant lecturer contact

00201552590309

mostafa.abdellah95@aun.edu.eg

Khaled Abd Elbaki Abd Elrahman, professor contact

00201008182061

khaledbaky@aun.edu.eg

Egypt1 site
  • Assiut university

    Asyut

    Mostafa Hassan Abdellah, assisstant lecturer, 00201552090309, darsh.bash@gmail.com

Other trials in Egypt

About this study

Official title: Comparison of 3% Hypertonic Saline Versus 20% Mannitol in Reduction of Increased Intracranial Pressure in Patients With Traumatic Brain Injury Using Optic Nerve Sheath Diameter Measurements''

The aim of this study to compare the efficacy of hypertonic saline and mannitol in reducing intracranial pressure, as assessed by serial optic nerve sheath diameter (ONSD) ultrasound measurements, in patients with traumatic brain injury.

Read the detailed description

Introduction :- Traumatic brain injury (TBI) remains a primary driver of global trauma-related mortality and severe long-term neurological disability. The pathophysiological trajectory of severe TBI involves a primary mechanical insult followed by a complex cascade of secondary brain injury evolving over subsequent hours and days. Primary injury arises directly from mechanical forces-inducing focal contusions, lacerations, or diffuse axonal disruption. Secondary brain injury develops through cellular and metabolic dysfunction, characterized by blood-brain barrier (BBB) disruption, neuroinflammation, microvascular ischemia, cellular energy failure, and severe cytotoxic and vasogenic cerebral edema. Within the non-yielding osseous structure of the adult cranium, progressive cerebral edema and expanding traumatic lesions directly precipitate pathological elevations in intracranial pressure (ICP).

The volumetric dynamics of the cranium are governed by the Monro-Kellie doctrine, which dictates that the sum of brain tissue, blood, and cerebrospinal fluid (CSF) volumes within the intracranial vault remains constant. Because the intracranial volume is fixed, any increase in parenchymal or hemorrhage volume must be compensated by an equal reduction in CSF and venous blood volume. Once these physiological buffering mechanisms are exhausted, intracranial compliance drops sharply, causing exponential surges in ICP. Brain Trauma Foundation (BTF) guidelines define intracranial hypertension as sustained ICP elevations exceeding 22 mmHg. Sustained intracranial hypertension directly compromises cerebral perfusion pressure (CPP = MAP - ICP), precipitating secondary ischemic insults, tissue hypoxia, loss of cerebrovascular autoregulation, and life-threatening transtentorial or tonsillar herniation syndromes. Clinical evidence demonstrates a strong correlation between unmanaged intracranial hypertension and adverse outcomes; mortality rates increase significantly when ICP exceeds 20 mmHg and can surpass 50% when ICP rises above 40 mmHg.

Hyperosmolar therapy is the standard medical management strategy for ICH after supportive care which is most important for neuroprotection (sedation, analgesia, position, and so on). Currently, only 2 osmotic agents are utilized for this purpose: mannitol and HTS. Mannitol has been the primary hyperosmolar agent for nearly a century and remains a common treatment for ICH. Guidelines currently recommend mannitol as the mainstay in the treatment of ICH.

Hyperosmolar therapy, remains a cornerstone of ICP management . Mannitol, a 6 carbon inert sugar alcohol approved by the FDA, reduces ICP by increasing plasma osmolality and promoting water efflux. It is routinely used to treat cerebral edema following brain insults and neurosurgical procedures. Despite its widespread use, some concerns persist due to its systemic effects. Case reports and small clinical series have described complications such as transient heart failure triggered by rapid intravascular volume shifts, impaired cardiac function in the elderly, hypotension, dehydration, acute kidney injury, and hypernatremia. Mannitol-induced diuresis may also cause hypovolemia in vulnerable patients.

For several decades, 20% Mannitol has been the primary osmotic agent in neurocritical care. Mannitol is a sugar alcohol solution with an osmolarity of approximately 1098 mOsm/L. Administered as intermittent IV boluses (0.5 - 1.0 g/kg), mannitol produces rapid intravascular volume expansion followed by pronounced renal osmotic diuresis. Although mannitol reduces ICP within 15 to 30 minutes, its diuretic mechanism can lead to systemic hypovolemia, arterial hypotension, hyperosmolality, electrolyte depletion, and acute tubular necrosis. Moreover, repeated dosing or continuous exposure can disrupt the blood-brain barrier, allowing mannitol to enter the brain parenchyma and induce rebound intracranial hypertension.

3% Hypertonic Saline (HTS) provides an alternative hyperosmolar strategy that expands intravascular volume without causing systemic diuresis. is available from 2 to 23.4% and can be administered as a bolus alone or with mannitol. Concentrations of HTS greater than 7.5% should be given through a central venous catheter. Concentrations less than 7.5% can be bolused via a peripheral line; however, infusions should be given in a large vessel. Administered as boluses (3 mL/kg or 150 mL) or continuous infusions, 3% NaCl has an osmolarity of approximately 1026 mOsm/L (513 mEq/L Na+). Hypertonic saline enhances cardiac preload and maintains mean arterial pressure, offering hemodynamic benefits in trauma patients susceptible to hypotension or hemorrhagic shock. Furthermore, hypertonic saline maintains blood-brain barrier integrity more effectively than mannitol, producing sustained ICP reduction with a lower frequency of rebound spikes. Potential adverse risks include hypernatremia, hyperchloremic metabolic acidosis, fluid overload, and osmotic demyelination syndrome if serum sodium shifts are unmonitored.

Neuromonitoring Modalities: Invasive Gold Standards and the Sonographic ONSD Window:

Accurate measurement of ICP is fundamental to neurocritical care, guiding hyperosmolar therapy, adjusting ventilator parameters, and preventing secondary ischemic injury. Invasive intracranial monitoring-utilizing intraventricular catheters connected to external ventricular drains (EVD) or parenchymal strain-gauge microtransducers-remains the diagnostic gold standard. Intraventricular catheters provide continuous pressure monitoring alongside the unique capacity for therapeutic CSF drainage to manage acute ICP spikes. Nevertheless, invasive modalities involve substantial clinical challenges, including risks of intracranial hemorrhage, bacterial ventriculitis, localized brain parenchymal trauma, and technical malposition. Furthermore, invasive placement requires neurosurgical expertise and specialized critical care resources that are frequently unavailable in pre-hospital environments, low-resource regional hospitals, or remote emergency units.

These diagnostic limitations have driven the development of point-of-care ultrasound (POCUS) techniques, with measurement of the optic nerve sheath diameter (ONSD) emerging as a non-invasive surrogate for ICP monitoring. Anatomically, the optic nerve is an extension of the central nervous system, encased in a dural sheath that represents a direct continuation of the intracranial meninges. The subarachnoid space surrounding the optic nerve communicates directly with the intracranial subarachnoid cavity, allowing CSF to flow freely between the two regions. Increases in ICP transmit hydrostatic pressure through the subarachnoid CSF, expanding the retrobulbar optic nerve sheath. Because the dural sheath is most elastic and distensible 3 mm posterior to the eye globe, high-frequency ultrasonographic measurements taken at this specific landmark correlate closely with invasively measured ICP.

Clinical studies indicate that an ONSD cutoff between 4.8 mm and 5.5 mm reliably detects intracranial pressure exceeding 20 mmHg with high sensitivity and specificity . Sonographic ONSD assessment is non-invasive, cost-effective, rapidly repeatable at the bedside, and free from surgical risks.

Clinical literature directly comparing 3% Hypertonic Saline versus 20% Mannitol specifically in Traumatic Brain Injury (TBI) patients using bedside Optic Nerve Sheath Diameter (ONSD) ultrasonography in Egyptian medical centers is limited, primarily consisting of small, single-center pilot studies.

Being tested
Mannitol (20%), Hypertonic Saline ( 3% Sodium Chloride Saline)
Keywords
mannitol, hypertonic saline, ICP, ONSD, TBI
Medical subject headings
Brain Injuries, Traumatic, Intracranial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mannitol (20%)Drug

    compare the efficacy of mannitol in reducing intracranial pressure, as assessed by serial optic nerve sheath diameter (ONSD) ultrasound measurements, in patients with traumatic brain injury.

  • Hypertonic Saline ( 3% Sodium Chloride Saline)Drug

    compare the efficacy of hypertoic saline in reducing intracranial pressure, as assessed by serial optic nerve sheath diameter (ONSD) ultrasound measurements, in patients with traumatic brain injury.

Study groups in NCT07786324
Study groupRoleWhat they receive
Group M (Mannitol)Active comparatorused ultrasonography to assess the optic nerve sheath diameter from Baseline or Immediately before mannitol therapy. Then added mannitol with Follow-up ONSD, 2 hours, 6 hours,24 hours using 20% Mannitol Dose: 0.5-1 g/kg IV over 15-20 minutes.
Receives: Drug: Mannitol (20%)
Group H (Hypertonic Saline)Active comparatorused ultrasonography to assess the optic nerve sheath diameter from Baseline or Immediately before hypertonic saline therapy. Then added hypertonic saline with Follow-up ONSD, 2 hours, 6 hours,24 hours used 3% Hypertonic saline at dose: 2-3 mL/kg IV over 15-20 minutes
Receives: Drug: Hypertonic Saline ( 3% Sodium Chloride Saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in ONSD (mm) from baseline, after treatment (e.g., at 2 hour, 6 hours, and 24 hours).

    Measured: 24 hours

Secondary outcomes (4)
  1. reduction of icp

    1. Time to achieve target ICP reduction following administration of the hyperosmolar agent., hemodynamic stability and the frequency of secondary rebound hypertension during acute resuscitation.

    Measured: 1 hours, 6 hours, 24hours

  2. GCS

    Change in Glasgow Coma Scale (GCS) after treatment.

    Measured: 24HOURS

  3. serum electrolyte

    Changes in serum electrolyte. sodium and osmolarity

    Measured: 6hours, 24hours

  4. surgery

    Requirement for surgical intervention.

    Measured: 24hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07786324
Sponsor's protocol ID
TBI-ONSD-2026
Acronym
MHTS-ONSD
Status last verified
Aug 2026
First submitted
13 Aug 2026
Last updated
25 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Trocha G, Bonilla A, Romero C, Palacios J, Molano-Gonzalez N. Ultrasound measurement of optic nerve sheath diameter in a healthy adult Colombian population. BMC Neurol. 2023 Jan 13;23(1):16. doi: 10.1186/s12883-023-03062-4.

    PubMed 36639617
  • Ramasamy A. Advanced trauma life support 2025: A brief review of updates. Injury. 2026 Apr;57(4):113079. doi: 10.1016/j.injury.2026.113079. Epub 2026 Feb 3.

    PubMed 41671886
  • Khalid S, Kim H, Kim HS. Recent trends in diabetes mellitus diagnosis: an in-depth review of artificial intelligence-based techniques. Diabetes Res Clin Pract. 2025 Jun;224:112221. doi: 10.1016/j.diabres.2025.112221. Epub 2025 May 4.

    PubMed 40328407
  • Hegde, Gayathri, P. Deepa Shenoy, and Arvind Canchi. "A deep learning framework for chronic kidney disease stage classification." Healthcare Analytics 7 (2025): 100398.

  • Rehman S, Afzal M. Blood Pressure Measurement. 2026 Feb 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482189/

    PubMed 29489154
  • Hakeem A, Anwer M, Khan AV, Kumar H, Karthikeyan V, Sridhar R, Kumar A, Kumar A, Kumar S. Optic Nerve Sheath Diameter Estimation to Detect Increased Intracranial Pressure in Traumatic Brain Injury patients at a Level I Trauma Center in Eastern India. Korean J Neurotrauma. 2025 Apr 24;21(2):93-101. doi: 10.13004/kjnt.2025.21.e15. eCollection 2025 Apr.

    PubMed 40353282
  • Zhang N, Liang M, Shao T, Li N, Wang K, Sun S, Sun T. Clinical implications of real-time optic nerve sheath diameter assessment via critical care ultrasound in intracranial hypertension. Front Neurol. 2025 Feb 13;16:1488482. doi: 10.3389/fneur.2025.1488482. eCollection 2025.

    PubMed 40027162
  • Fahmy, H., A. Mohamady, and A. Abdelaziz. "Optic nerve sheath diameter: an ultrasonographic window for comparing between hypertonic saline and mannitol in severe traumatic brain injuries." Journal of Anesthesia and Clinical Research 10.4 (2019): 888-894.

  • Robba C, Picetti E, Vasquez-Garcia S, Abulhasan YB, Ain A, Adeleye AO, Aries M, Brasil S, Badenes R, Bertuccio A, Bouzat P, Bustamante L, Calabro' L, Njimi H, Cardim D, Citerio G, Czosnyka M, Geeraerts T, Godoy DA, Hirzallah MI, Devi BI, Jibaja M, Lochner P, Mijangos Mendez JC, Meyfroidt G, Munusamy T, Portilla JP, Prabhakar H, Rasulo F, Sanchez Parra DM, Sarwal A, Shrestha GS, Shukla DP, Sung G, Tirsit A, Vasquez F, Videtta W, Wang YL, Paiva WS, Taccone FS, Rubiano AM. The Brussels consensus for non-invasive ICP monitoring when invasive systems are not available in the care of TBI patients (the B-ICONIC consensus, recommendations, and management algorithm). Intensive Care Med. 2025 Jan;51(1):4-20. doi: 10.1007/s00134-024-07756-2. Epub 2025 Jan 23.

    PubMed 39847066
  • Jiang X, Guo H, Xiao W, Wang L, Wu D, Liu J, Zhao Q, Shao Y. Advancements in Non-Invasive Intracranial Pressure Monitoring via Optic Nerve Sheath Diameter Measurement. Med Sci Monit. 2025 May 25;31:e947237. doi: 10.12659/MSM.947237.

    PubMed 40413578
  • Patel S, Maria-Rios J, Parikh A, Okorie ON. Diagnosis and management of elevated intracranial pressure in the emergency department. Int J Emerg Med. 2023 Oct 13;16(1):72. doi: 10.1186/s12245-023-00540-x.

    PubMed 37833652
  • Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.

    PubMed 27654000
  • Kareemi H, Pratte M, English S, Hendin A. Initial Diagnosis and Management of Acutely Elevated Intracranial Pressure. J Intensive Care Med. 2023 Jul;38(7):643-650. doi: 10.1177/08850666231156589. Epub 2023 Feb 19.

    PubMed 36802976
  • Bianchini L, de Matos PMPG, Roepke RML, Besen BAMP. Management of intracranial hypertension with and without invasive intracranial pressure monitoring. World J Crit Care Med. 2025 Sep 9;14(3):105645. doi: 10.5492/wjccm.v14.i3.105645. eCollection 2025 Sep 9.

    PubMed 40880574
  • Viarasilpa T. Managing Intracranial Pressure Crisis. Curr Neurol Neurosci Rep. 2024 Dec 19;25(1):12. doi: 10.1007/s11910-024-01392-5.

    PubMed 39699775

Questions about this trial

What is this clinical trial studying?

A study testing Mannitol (20%) and Hypertonic Saline ( 3% Sodium Chloride Saline) in people with TBI (Traumatic Brain Injury) and ICP (Intracranial Pressure) Increase, run by Assiut 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 4 inclusion and 10 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 25 Aug 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 Hassan Abdellah, assisstant lecturer (00201552590309, mostafa.abdellah95@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in ONSD (mm) from baseline, after treatment (e.g., at 2 hour, 6 hours, and 24 hours). (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07786324, which also lists 17 linked publications.

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 25 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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