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

RecruitingPhase 2Ages 18 Years - anyAllErasme University Hospital
NCT07625995 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 neu

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📋 Eligibility rules (as published)
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
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What it tests

  • Neutral Fluid Balance Strategy
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Where

3 sites
Erasme University Hospital
Brussels, Belgium
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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