NCT07625995 Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients- LIMIT-TBI Trial
| NCT ID | NCT07625995 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Erasme University Hospital |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 88 participants in total. It began in 2025-07-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07625995 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07625995 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07625995 currently recruiting?
Yes, NCT07625995 is actively recruiting participants. Contact the research team at fabio.taccone@hubruxelles.be for enrollment information.
Where is the NCT07625995 trial being conducted?
This trial is being conducted at Brussels, Belgium, Genova, Italy, Roma, Italy.
Who is sponsoring the NCT07625995 clinical trial?
NCT07625995 is sponsored by Erasme University Hospital. The trial plans to enroll 88 participants.