Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients- LIMIT-TBI Trial
Recruiting now · Phase 2
Conditions studied: Traumatic Brain Injury, Severe Traumatic Brain Injury, Acute Brain Injury, Neurocritical Care
In brief
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.
Key facts
- Study ID
- NCT07625995
- Run by
- Erasme University Hospital
- People needed
- 88
- Starts
- 2025-07-01
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Erasme University Hospital — Brussels, Belgium (enrolling)
- IRCCS Ospedale Policlinico San Martino — Genova, Italy (enrolling)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (enrolling)
Full record on ClinicalTrials.gov
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