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Can keeping fluid levels neutral help brain injury patients?

NCT ID NCT07625995

Disease control Sponsor: Erasme University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tests whether keeping fluid balance neutral (close to zero) is safe and feasible for adults with traumatic brain injury in the ICU. 88 participants will be randomly assigned to either a neutral fluid strategy or standard care for 5 days. The goal is to see if this approach can be achieved and whether it reduces complications.

What this could mean

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

Active substance
Neutral fluid balance strategy (restricted fluids, diuretics, vasopressors)
What this could lead to
If successful, this could establish a safer way to manage fluids in brain injury patients, potentially reducing complications and improving recovery.
What could go wrong
This is an early phase II trial with only 88 participants, so results may not apply to all patients. The strategy may be difficult to achieve or could cause harm like low blood pressure or kidney issues.

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 88 people

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

Started

Jul 2025

Expected to finish

Feb 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: * Adult patients with traumatic brain injury (isolated or associated with extracranial injuries), with or without intracranial pressure monitoring * Admission to the intensive care unit * Age \>18 years * Enrollment within 48 hours after ICU admission Exclusion Criteria: * Enrollment in another clinical trial not approved for co-enrollment * Pregnancy or suspected pregnancy * Concomitant hemorrhagic shock expected to require surgical treatment within 24 hours from inclusion or requiring massive transfusion protocol * Hemodynamic instability at ICU admission, defined as heart rate \>120 beats/min and systolic arterial pressure \<100 mmHg despite at least 1 L of fluid resuscitation, or requirement for high-dose norepinephrine (\>0.5 mcg/kg/min) or any inotropic support * Need for continuous venovenous hemodiafiltration (CVVHDF) at admission * Expected survival \<48 hours

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic brain injury traumatic brain injury

As listed by the trial registrant

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

Acute brain injury Neurocritical care Severe traumatic brain injury 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

    3 sites in 2 countries. 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

  • Erasme University Hospital

    RECRUITING

    Brussels, 1070, Belgium

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • IRCCS Ospedale Policlinico San Martino

    RECRUITING

    Genova, 16132, Italy

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