Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients- LIMIT-TBI Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasme University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Neutral Fluid Balance Strategy
Other interventionProtocolized 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.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Neutral Fluid Balance StrategyExperimental treatment 1 intervention
Group B: Standard of Care Fluid ManagementNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility of achieving a neutral daily fluid balance
Proportion of patients achieving a mean daily fluid balance within 0 ± 500 mL during the 5 days after ICU admission - mean daily fluid balance will be measured at day 5 as the mean of the fluid balances of the 5 previous days
Time frame
At 5 days after randomisationSecondary outcomes
1
Incidence of systemic organ complications
Incidence of new organ dysfunction or complications during ICU stay.
Time frame
ICU discharge2
Cerebral perfusion pressure (CPP)
Mean and daily cerebral perfusion pressure during ICU stay.
Time frame
From randomisation to day 5 after randomisation3
Daily fluid balance and fluid input
Mean daily fluid balance and total fluid input during the first 5 days
Time frame
From randomisation to day 5 after randomisation4
Vasopressor and diuretic use
Total and daily dose of vasopressors and diuretics during ICU stay.
Time frame
ICU dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasme University Hospital
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Azienda Ospedaliero, Universitaria Pisana
Collaborator
Hospital Clínico Universitario de Valencia
Collaborator
All India Institute of Medical Sciences
Collaborator
Erasmus University Rotterdam
Collaborator
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Collaborator
Source ClinicalTrials.gov