NCT07786324

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
37mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

2.6 years

First QC Date

August 13, 2026

Last Update Submit

August 21, 2026

Conditions

TBI (Traumatic Brain Injury)ICP (Intracranial Pressure) IncreaseOptic Nerve Sheath Diameter Measurement

Keywords

mannitolhypertonic salineICPONSDTBI

Outcome Measures

Primary Outcomes (1)

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

    24 hours

Secondary Outcomes (4)

  • reduction of icp

    1 hours, 6 hours, 24hours

  • GCS

    24HOURS

  • serum electrolyte

    6hours, 24hours

  • surgery

    24hours

Study Arms (2)

Group M (Mannitol)

ACTIVE COMPARATOR

used 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.

Drug: Mannitol (20%)

Group H (Hypertonic Saline)

ACTIVE COMPARATOR

used 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

Drug: Hypertonic Saline ( 3% Sodium Chloride Saline)

Interventions

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.

Group M (Mannitol)
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.

Group H (Hypertonic Saline)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Penetrating head injury.
  • Hypotension.
  • Previous ocular trauma or orbital surgery.
  • Glaucoma or optic nerve pathology.
  • Bilateral ocular injuries preventing ultrasound assessment.
  • Pregnancy.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (17)

  • 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.

    PMID: 36639617RESULT

  • 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.

    PMID: 41671886RESULT

  • 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.

    PMID: 40328407RESULT

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

    RESULT

  • 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/

    PMID: 29489154RESULT

  • 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.

    PMID: 40353282RESULT

  • 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.

    PMID: 40027162RESULT

  • 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.

    RESULT

  • 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.

    PMID: 39847066RESULT

  • 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.

    PMID: 40413578RESULT

  • 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.

    PMID: 37833652RESULT

  • 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.

    PMID: 27654000RESULT

  • 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.

    PMID: 36802976RESULT

  • 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.

    PMID: 40880574RESULT

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

    PMID: 39699775RESULT

  • Benson JC, Madhavan AA, Cutsforth-Gregory JK, Johnson DR, Carr CM. The Monro-Kellie Doctrine: A Review and Call for Revision. AJNR Am J Neuroradiol. 2023 Jan;44(1):2-6. doi: 10.3174/ajnr.A7721. Epub 2022 Dec 1.

    PMID: 36456084RESULT

  • Georges A, Das JM. Traumatic Brain Injury (Archive). 2024 Feb 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459300/

    PMID: 29083790RESULT

Related Links

MeSH Terms

Conditions

Brain Injuries, TraumaticIntracranial Hypertension

Interventions

MannitolSaline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesHypertonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Mostafa Hassan Abdellah, assisstant lecturer

CONTACT

00201552590309mostafa.abdellah95@aun.edu.eg

Khaled Abd Elbaki Abd Elrahman, professor

CONTACT

00201008182061khaledbaky@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor (assisstant lecturer)

Study Record Dates

First Submitted

August 13, 2026

First Posted

August 25, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

September 30, 2029

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)