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

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.

NCT Number	NCT07625995
Lead Sponsor	Erasme University Hospital Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Ospedaliero, Universitaria Pisana, Hospital Clínico Universitario de Valencia, All India Institute of Medical Sciences, Erasmus University Rotterdam, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Conditions	Traumatic Brain Injury, Severe Traumatic Brain Injury, Acute Brain Injury, Neurocritical Care
Enrollment	88 participants
Start Date	2025-07-01
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-02 (estimated)
Updated on ClinicalTrials.gov	2026-06-04