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Study identifier: NCT07625995 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients- LIMIT-TBI Trial

Condition: Traumatic Brain Injury · Severe Traumatic Brain Injury · Acute Brain Injury  ·  Sponsor: Erasme University Hospital

PhasePhase 2
Planned participants88
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The LIMIT-TBI trial is a multicenter, international, randomized, phase II clinical trial designed to evaluate the feasibility and safety of targeting a neutral fluid balance compared to standard care in critically ill adult patients with traumatic brain injury (TBI). Fluid therapy is a cornerstone of TBI management, but optimal fluid balance remains uncertain, with both fluid overload and restriction potentially leading to adverse outcomes. This study aims to determine whether maintaining a daily fluid balance close to zero (±500 mL) during the first 5 days of ICU admission is achievable and safe. Participants will be randomized within 48 hours of ICU admission to either a protocolized neutral fluid balance strategy or standard care. Outcomes include feasibility of achieving the target balance, organ complications, hemodynamic parameters, ICU resource utilization, and mortality and neurological outcomes up to 6 months.

This description comes directly from the study's public registry record.

Talk to the study team

Fabio Silvio Taccone, MD, PhD  ·  +32 2 555 33 95  ·  fabio.taccone@hubruxelles.be

Always discuss trial participation with your own doctor first.

Locations (3)

Erasme University HospitalBrussels, BelgiumRecruiting
IRCCS Ospedale Policlinico San MartinoGenova, ItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07625995