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Which works faster: saline or mannitol for brain swelling?

NCT ID NCT07786324

Disease control Sponsor: Assiut University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial compares two common treatments—hypertonic saline and mannitol—to see which is better at reducing dangerously high pressure inside the skull after a severe traumatic brain injury. The study includes 100 adults with severe head injuries and uses a simple ultrasound measurement of the optic nerve sheath to track pressure changes. The goal is to find the most effective way to protect the brain during the critical first hours after injury.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hypertonic saline (3% sodium chloride) and mannitol (20%)
What this could lead to
If one treatment works better, it could become the preferred option for quickly lowering brain pressure after traumatic brain injury, potentially improving recovery.
What could go wrong
This is a single-center trial with 100 patients, so results may not apply broadly. Both treatments can cause side effects like electrolyte imbalances or blood pressure changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * • 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. Exclusion Criteria: * • 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.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic intracranial hypertension traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Icp (intracranial pressure) increase Optic nerve sheath diameter measurement TBI (traumatic brain injury)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Assiut university

    Asyut, Egypt

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