Condition: Traumatic Brain Injury · Severe Traumatic Brain Injury · Acute Brain Injury · Sponsor: Erasme University Hospital
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.
Fabio Silvio Taccone, MD, PhD · +32 2 555 33 95 · fabio.taccone@hubruxelles.be
Always discuss trial participation with your own doctor first.
| Erasme University Hospital | Brussels, Belgium | Recruiting |
| IRCCS Ospedale Policlinico San Martino | Genova, Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07625995