Neutral fluid balance in adults with traumatic brain injury (LIMIT-TBI)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

LIMIT-TBI is a multicenter, international phase II trial that randomizes adults with traumatic brain injury within 48 hours of ICU admission to either a protocolized neutral fluid balance or standard care. The neutral strategy uses controlled fluid administration, vasopressors, and diuretics to reach a daily balance near 0 mL (±500 mL) for the first 5 days. The trial measures feasibility of achieving the target balance, organ complications, hemodynamics, ICU resource use, and 6-month mortality and neurological outcomes. It aims to clarify whether neutral fluid balance can improve outcomes without compromising safety in severe TBI. Enrollment is in ICU settings with ongoing monitoring of intracranial pressure when applicable.

Why it matters

Who can join: the full rules

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

Where it's running

• Erasme University Hospital
  Brussels, Belgium Recruiting
• IRCCS Ospedale Policlinico San Martino
  Genova, Italy Recruiting
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  Roma, Italy Recruiting

Study contacts

• Study coordinator: Fabio Silvio Taccone, MD, PhD
• Email: fabio.taccone@hubruxelles.be
• Phone: +32 2 555 33 95

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.