RecruitingPhase 2NCT07625995

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

Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients: a Phase II Randomized Controlled Trial - LIMIT-TBI Trial


Sponsor

Erasme University Hospital

Enrollment

88 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Neutral Fluid Balance Strategy for people with acute brain injury, neurocritical care, and other related conditions. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNeutral Fluid Balance Strategy

Protocolized strategy targeting a daily fluid balance of 0 ± 500 mL for 5 days using restricted fluids, diuretics, and vasopressors to maintain hemodynamic and cerebral perfusion targets.


Locations(3)

Erasme University Hospital

Brussels, Belgium

IRCCS Ospedale Policlinico San Martino

Genova, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

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NCT07625995


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