[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640910":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":23,"locations":29,"responsibleParty":75,"collaborators":79,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":18,"enrollmentInfo":101,"targetDuration":18,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":31,"whyStopped":18,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Erasme University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Neutral Fluid Balance Strategy","EXPERIMENTAL","Participants randomized to the experimental arm will receive a protocolized fluid management strategy targeting a neutral fluid balance (0 ± 500 mL per day) during the first 5 days following ICU admission.\n\nAll fluid inputs (intravenous fluids, medications, enteral nutrition) and outputs (urine, drains, gastrointestinal losses, etc.) will be strictly monitored and included in the daily balance calculation.\n\nFluid administration will be minimized, and no routine maintenance fluids will be administered unless required to ensure a minimum daily intake of approximately 1 L (including medications and nutrition).\n\nIf the daily fluid balance exceeds ±500 mL, adjustments will be made in subsequent days by reducing fluid administration and\u002For introducing diuretics to achieve cumulative neutrality.\n\nHemodynamic targets (mean arterial pressure ≥70 mmHg, systolic arterial pressure ≥100 mmHg, and\u002For cerebral perfusion pressure ≥60 mmHg) will be maintained using vasopressors (e.g., norepinephrine)",[13],"Other: Neutral Fluid Balance Strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care Fluid Management","NO_INTERVENTION","Participants randomized to the control arm will receive standard fluid management according to local ICU practice and clinician judgment.\n\nIntravenous fluids may be administered as maintenance therapy if part of local protocols, and to correct hypovolemia, dehydration, electrolyte imbalances, or ongoing losses.\n\nHemodynamic targets, including cerebral perfusion pressure, will be achieved using fluids and\u002For vasopressors at the discretion of the treating clinician, without a predefined protocol for fluid balance.\n\nFluid balance will be monitored but no specific target for neutrality will be enforced.",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"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.",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"Fabio Silvio Taccone, MD, PhD","CONTACT","+32 2 555 33 95","fabio.taccone@hubruxelles.be",[30,45,61],{"facility":5,"status":31,"city":32,"state":18,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Brussels","1070","Belgium","BE",{"type":37,"coordinates":38},"Point",[39,40],4.34878,50.85045,{"lat":40,"lon":39},[43],{"name":44,"role":26,"phone":27,"phoneExt":18,"email":28},"Fabio Silvio Taccone, MD,Phd",{"facility":46,"status":31,"city":47,"state":18,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"IRCCS Ospedale Policlinico San Martino","Genova","16132","Italy","IT",{"type":37,"coordinates":52},[53,54],11.87211,45.21604,{"lat":54,"lon":53},[57],{"name":58,"role":26,"phone":59,"phoneExt":18,"email":60},"Chiara Robba, MD","+3910 555 4970","chiara.robba@unige.it",{"facility":62,"status":31,"city":63,"state":18,"zip":64,"country":49,"countryCode":50,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Roma","00168",{"type":37,"coordinates":66},[67,68],11.10642,44.99364,{"lat":68,"lon":67},[71],{"name":72,"role":26,"phone":73,"phoneExt":18,"email":74},"Anselmo Caricato, MD","+396 3015 4490","anselmo.caricato@unicatt.it",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Fabio Taccone","Head of department of Intensive care, Clinical Professor, Principal investigator",[80,81,83,85,87,89],{"name":62,"class":6},{"name":82,"class":6},"Azienda Ospedaliero, Universitaria Pisana",{"name":84,"class":6},"Hospital Clínico Universitario de Valencia",{"name":86,"class":6},"All India Institute of Medical Sciences",{"name":88,"class":6},"Erasmus University Rotterdam",{"name":90,"class":6},"IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy","100640910","phase-2-feasibility-and-safety-of-targeting-neutral-vs-liberal-fluid-balance-in-traumatic-brain-injured-patients--limit-tbi-trial-100640910",false,"NCT07625995","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","LIMIT-TBI","Inclusion Criteria:\n\n* Adult patients with traumatic brain injury (isolated or associated with extracranial injuries), with or without intracranial pressure monitoring\n* Admission to the intensive care unit\n* Age \\>18 years\n* Enrollment within 48 hours after ICU admission\n\nExclusion Criteria:\n\n* Enrollment in another clinical trial not approved for co-enrollment\n* Pregnancy or suspected pregnancy\n* Concomitant hemorrhagic shock expected to require surgical treatment within 24 hours from inclusion or requiring massive transfusion protocol\n* Hemodynamic instability at ICU admission, defined as heart rate \\>120 beats\u002Fmin and systolic arterial pressure \\\u003C100 mmHg despite at least 1 L of fluid resuscitation, or requirement for high-dose norepinephrine (\\>0.5 mcg\u002Fkg\u002Fmin) or any inotropic support\n* Need for continuous venovenous hemodiafiltration (CVVHDF) at admission\n* Expected survival \\\u003C48 hours","ALL","18 Years",{"count":102,"type":103},88,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","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).\n\nFluid 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.\n\nParticipants 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.",[109,110,111,112],"Traumatic Brain Injury","Severe Traumatic Brain Injury","Acute Brain Injury","Neurocritical Care",[114,115,116,117,118],"Fluid Balance","Fluid Therapy","Hemodynamic Management","Feasibility Study","Intracranial Pressure","2026-05-30",{"date":121,"type":122},"2026-06-04","ACTUAL",{"date":124,"type":122},"2025-07-01",{"date":126,"type":103},"2029-02",{"name":5,"class":6},3]