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Could a simple salt solution help the brain after severe injury?

NCT ID NCT06701760

Disease control Sponsor: University of California, Los Angeles 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a sodium lactate infusion is safe for people with severe traumatic brain injury in the ICU. Researchers will monitor side effects and survival in 264 adults. The goal is to see if this approach is safe enough to study further.

What this could mean

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

Active substance
sodium lactate
What this could lead to
If safe, this could point toward a new way to manage severe traumatic brain injury in the ICU.
What could go wrong
This is an early safety trial, so it may not show any benefit. The treatment is only for a specific group of patients with severe injuries.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 264 people

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

Expected to start

Jan 2028

An estimate. Start dates often move.

Expected to finish

Jul 2038

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 to 80 years

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: * GCS at enrollment 3-8 * Male or female aged 18-80 at admission * acute positive CT findings * ability for subject to comply with the requirements of the study * written informed consent obtained from subject or subject's legal representative. Exclusion Criteria: * Penetrating TBI * Polytrauma leading to instability of systemic: hemodynamics, acidosis, or severe acute lung injury during the inclusion period * History of neurological disease, including Parkinson's, Huntington's, Alzheimer's, etc. * History of diabetes mellitus * Serum sodium ≥ 148 mM * Metabolic acidosis pH \<7.34 * Coagulopathy INR \> 1.3, platelets \< 100,000, or hematocrit \< 28 mg/dl * Renal insufficiency with GFR \< 60% of expected or Cr \> 1.3; * AST or ALT \> 1.5x upper limit of normal; Severe liver trauma; * baseline serum lactate \> 2 mM * Hypotension SBP \< 90 refractory to vasopressors * Known mitochondrial genetic disorder * Pregnancy * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data * Member of a protected population; simultaneous participation in another randomized trial

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic Coma traumatic brain injury

As listed by the trial registrant

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

Traumatic brain injury

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.