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

Study acronym: LIMIT-TBI
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
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
(from sponsor)
Traumatic Brain Injury, Severe Traumatic Brain Injury, Acute Brain Injury, Neurocritical Care
Related terms Brain Injuries, Brain Injuries, Traumatic
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov