Traumatic Brain InjuryPhase 2LIMIT-TBINCT07625995
Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients- LIMIT-TBI Trial
A Phase 2 study testing Neutral Fluid Balance Strategy in people with Traumatic Brain Injury and Severe Traumatic Brain Injury, run by Erasme University Hospital at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Severe Traumatic Brain Injury, Acute Brain Injury
- What is being tested?
- Neutral Fluid Balance Strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jul 2025to Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genova, 16132
Chiara Robba, MD, +3910 555 4970, chiara.robba@unige.it
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Anselmo Caricato, MD, +396 3015 4490, anselmo.caricato@unicatt.it
Belgium1 site, 1 recruiting
- Recruiting
Erasme University Hospital
Brussels, 1070
Fabio Silvio Taccone, MD,Phd, +32 2 555 33 95, fabio.taccone@hubruxelles.be
About this study
Official title: Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients: a Phase II Randomized Controlled Trial - LIMIT-TBI 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.
Read the detailed description
Severe traumatic brain injury (TBI) is a major cause of mortality and long-term disability worldwide and frequently requires intensive care management. In these patients, preventing secondary brain injury is essential and involves optimizing cerebral perfusion pressure (CPP), systemic hemodynamics, and organ function. Fluid therapy plays a central role in achieving these goals.
However, the optimal fluid management strategy in TBI remains unclear. Excessive fluid administration may lead to complications such as pulmonary edema and worsening cerebral edema, while restrictive strategies may increase the risk of hypovolemia and impaired cerebral perfusion. Current guidelines provide limited or no specific recommendations due to the lack of high-quality randomized evidence. Observational data suggest that a more positive fluid balance is associated with worse outcomes, but causality has not been established.
The LIMIT-TBI trial is a pragmatic, international, multicenter, randomized, unblinded, parallel-group phase II study designed to address this evidence gap. Adult patients with TBI admitted to the ICU will be randomized within 48 hours in a 1:1 ratio to either:
A neutral fluid balance strategy, targeting a daily balance of 0 mL (±500 mL) and cumulative neutrality over the first 5 days, using a protocolized approach combining fluid restriction, vasopressors, and diuretics when needed; A standard of care strategy, in which fluid administration is guided by local practice and clinician judgment.
In the intervention group, all fluid inputs (intravenous fluids, medications, and enteral nutrition) and outputs are strictly monitored. Maintenance fluids are minimized, and adjustments are made daily to achieve neutrality while maintaining adequate mean arterial pressure and cerebral perfusion pressure targets.
The primary objective is to assess the feasibility and safety of achieving a neutral fluid balance, defined as maintaining a daily balance within ±500 mL. Secondary outcomes include systemic complications, hemodynamic parameters (including CPP), fluid administration metrics, vasopressor and diuretic use, organ support-free days, and ICU/hospital mortality. Long-term outcomes include 6-month mortality and neurological status assessed using the Glasgow Outcome Scale Extended (GOSE).
A total of 88 patients will be enrolled to provide adequate power to detect differences in fluid balance between groups. Statistical analyses will include linear mixed models for repeated measures and appropriate comparative tests for secondary outcomes, with multiple imputation for missing primary endpoint data.
This trial will provide important preliminary randomized evidence on fluid management in TBI and inform the design of future large-scale trials aimed at improving outcomes in this high-risk population.
- Conditions
- Traumatic Brain Injury, Severe Traumatic Brain Injury, Acute Brain Injury, Neurocritical Care
- Being tested
- Neutral Fluid Balance Strategy
- Keywords
- Fluid Balance, Fluid Therapy, Hemodynamic Management, Feasibility Study, Intracranial Pressure
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral Fluid Balance StrategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.
All 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.
Fluid 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).
If the daily fluid balance exceeds ±500 mL, adjustments will be made in subsequent days by reducing fluid administration and/or introducing diuretics to achieve cumulative neutrality.
Hemodynamic targets (mean arterial pressure ≥70 mmHg, systolic arterial pressure ≥100 mmHg, and/or cerebral perfusion pressure ≥60 mmHg) will be maintained using vasopressors (e.g., norepinephrine) Receives: Other: Neutral Fluid Balance Strategy |
| 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. Intravenous fluids may be administered as maintenance therapy if part of local protocols, and to correct hypovolemia, dehydration, electrolyte imbalances, or ongoing losses. Hemodynamic targets, including cerebral perfusion pressure, will be achieved using fluids and/or vasopressors at the discretion of the treating clinician, without a predefined protocol for fluid balance. Fluid balance will be monitored but no specific target for neutrality will be enforced. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 5 days after randomisation
Secondary outcomes (11)
Incidence of systemic organ complications
Incidence of new organ dysfunction or complications during ICU stay.
Measured: ICU discharge
Cerebral perfusion pressure (CPP)
Mean and daily cerebral perfusion pressure during ICU stay.
Measured: From randomisation to day 5 after randomisation
Daily fluid balance and fluid input
Mean daily fluid balance and total fluid input during the first 5 days
Measured: From randomisation to day 5 after randomisation
Vasopressor and diuretic use
Total and daily dose of vasopressors and diuretics during ICU stay.
Measured: ICU discharge
Vasopressor-free days
Number of days alive and free from vasopressor support.
Measured: From randomisation to day 28 after randomisation
Ventilator-free days
Number of days alive and free from invasive mechanical ventilation.
Measured: From randomisation to day 28 after randomisation
Therapy intensity level (TIL)
Maximum therapy intensity level during the intervention period.
Measured: At day 5 after randomisation
ICU and hospital mortality
All-cause mortality during ICU and hospital stay.
Measured: Hospital discharge
Neurological outcome (GOSE)
Functional neurological outcome assessed by Glasgow Outcome Scale Extended.
Measured: Hospital discharge
Long-term mortality
All-cause mortality at follow-up.
Measured: 180 days after randomization
Long-term neurological outcome (GOSE)
Functional neurological outcome assessed by Glasgow Outcome Scale Extended. Scale 1 to 8, 1= dead; 8=good recovery no social and mental deficits
Measured: 180 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Restrictive Fluid Management Strategy (INTERVENTION) vs. Routine Fluid Management Strategy (CONTROL)
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Ospedaliero, Universitaria Pisana, Hospital Clínico Universitario de Valencia, All India Institute of Medical Sciences, Erasmus University Rotterdam, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Responsible party
- Principal investigator, Fabio Taccone, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625995
- Sponsor's protocol ID
- SRB2023231
- Acronym
- LIMIT-TBI
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wiegers EJA, Lingsma HF, Huijben JA, Cooper DJ, Citerio G, Frisvold S, Helbok R, Maas AIR, Menon DK, Moore EM, Stocchetti N, Dippel DW, Steyerberg EW, van der Jagt M; CENTER-TBI; OzENTER-TBI Collaboration Groups. Fluid balance and outcome in critically ill patients with traumatic brain injury (CENTER-TBI and OzENTER-TBI): a prospective, multicentre, comparative effectiveness study. Lancet Neurol. 2021 Aug;20(8):627-638. doi: 10.1016/S1474-4422(21)00162-9.
PubMed 34302787Oddo M, Poole D, Helbok R, Meyfroidt G, Stocchetti N, Bouzat P, Cecconi M, Geeraerts T, Martin-Loeches I, Quintard H, Taccone FS, Geocadin RG, Hemphill C, Ichai C, Menon D, Payen JF, Perner A, Smith M, Suarez J, Videtta W, Zanier ER, Citerio G. Fluid therapy in neurointensive care patients: ESICM consensus and clinical practice recommendations. Intensive Care Med. 2018 Apr;44(4):449-463. doi: 10.1007/s00134-018-5086-z. Epub 2018 Mar 2.
PubMed 29500701Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
PubMed 27654000Messina A, Bakker J, Chew M, De Backer D, Hamzaoui O, Hernandez G, Myatra SN, Monnet X, Ostermann M, Pinsky M, Teboul JL, Cecconi M. Pathophysiology of fluid administration in critically ill patients. Intensive Care Med Exp. 2022 Nov 4;10(1):46. doi: 10.1186/s40635-022-00473-4.
PubMed 36329266Clifton GL, Miller ER, Choi SC, Levin HS. Fluid thresholds and outcome from severe brain injury. Crit Care Med. 2002 Apr;30(4):739-45. doi: 10.1097/00003246-200204000-00003.
PubMed 11940738Majdan M, Plancikova D, Brazinova A, Rusnak M, Nieboer D, Feigin V, Maas A. Epidemiology of traumatic brain injuries in Europe: a cross-sectional analysis. Lancet Public Health. 2016 Dec;1(2):e76-e83. doi: 10.1016/S2468-2667(16)30017-2. Epub 2016 Nov 29.
PubMed 29253420
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients: a Phase II Randomized Controlled Trial - LIMIT-TBI Trial
- ClinicalTrials.gov ID
- NCT07625995
- Acronym / sponsor ID
- LIMIT-TBI / SRB2023231
- Conditions
- Traumatic Brain Injury, Severe Traumatic Brain Injury, Acute Brain Injury, Neurocritical Care
- Keywords
- Fluid Balance, Fluid Therapy, Hemodynamic Management, Feasibility Study, Intracranial Pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Ospedaliero, Universitaria Pisana, Hospital Clínico Universitario de Valencia, All India Institute of Medical Sciences, Erasmus University Rotterdam, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Severe traumatic brain injury (TBI) is a major cause of mortality and long-term disability worldwide and frequently requires intensive care management. In these patients, preventing secondary brain injury is essential and involves optimizing cerebral perfusion pressure (CPP), systemic hemodynamics, and organ function. Fluid therapy plays a central role in achieving these goals.
However, the optimal fluid management strategy in TBI remains unclear. Excessive fluid administration may lead to complications such as pulmonary edema and worsening cerebral edema, while restrictive strategies may increase the risk of hypovolemia and impaired cerebral perfusion. Current guidelines provide limited or no specific recommendations due to the lack of high-quality randomized evidence. Observational data suggest that a more positive fluid balance is associated with worse outcomes, but causality has not been established.
The LIMIT-TBI trial is a pragmatic, international, multicenter, randomized, unblinded, parallel-group phase II study designed to address this evidence gap. Adult patients with TBI admitted to the ICU will be randomized within 48 hours in a 1:1 ratio to either:
A neutral fluid balance strategy, targeting a daily balance of 0 mL (±500 mL) and cumulative neutrality over the first 5 days, using a protocolized approach combining fluid restriction, vasopressors, and diuretics when needed; A standard of care strategy, in which fluid administration is guided by local practice and clinician judgment.
In the intervention group, all fluid inputs (intravenous fluids, medications, and enteral nutrition) and outputs are strictly monitored. Maintenance fluids are minimized, and adjustments are made daily to achieve neutrality while maintaining adequate mean arterial pressure and cerebral perfusion pressure targets.
The primary objective is to assess the feasibility and safety of achieving a neutral fluid balance, defined as maintaining a daily balance within ±500 mL. Secondary outcomes include systemic complications, hemodynamic parameters (including CPP), fluid administration metrics, vasopressor and diuretic use, organ support-free days, and ICU/hospital mortality. Long-term outcomes include 6-month mortality and neurological status assessed using the Glasgow Outcome Scale Extended (GOSE).
A total of 88 patients will be enrolled to provide adequate power to detect differences in fluid balance between groups. Statistical analyses will include linear mixed models for repeated measures and appropriate comparative tests for secondary outcomes, with multiple imputation for missing primary endpoint data.
This trial will provide important preliminary randomized evidence on fluid management in TBI and inform the design of future large-scale trials aimed at improving outcomes in this high-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Restrictive Fluid Management Strategy (INTERVENTION) vs. Routine Fluid Management Strategy (CONTROL)
| Arm | Type | Receives |
|---|---|---|
| Neutral Fluid Balance Strategy | Experimental | Other: Neutral Fluid Balance StrategyParticipants 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. All 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. Fluid 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). If the daily fluid balance exceeds ±500 mL, adjustments will be made in subsequent days by reducing fluid administration and/or introducing diuretics to achieve cumulative neutrality. Hemodynamic targets (mean arterial pressure ≥70 mmHg, systolic arterial pressure ≥100 mmHg, and/or cerebral perfusion pressure ≥60 mmHg) will be maintained using vasopressors (e.g., norepinephrine) |
| 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. Intravenous fluids may be administered as maintenance therapy if part of local protocols, and to correct hypovolemia, dehydration, electrolyte imbalances, or ongoing losses. Hemodynamic targets, including cerebral perfusion pressure, will be achieved using fluids and/or vasopressors at the discretion of the treating clinician, without a predefined protocol for fluid balance. Fluid balance will be monitored but no specific target for neutrality will be enforced. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutral Fluid Balance StrategyProtocolized 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. | Other | Neutral Fluid Balance Strategy |
Primary outcome
Feasibility of achieving a neutral daily fluid balance
Time frame: At 5 days after randomisation
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
11 secondary outcomes
Incidence of systemic organ complications
Time frame: ICU discharge
Cerebral perfusion pressure (CPP)
Time frame: From randomisation to day 5 after randomisation
Daily fluid balance and fluid input
Time frame: From randomisation to day 5 after randomisation
Vasopressor and diuretic use
Time frame: ICU discharge
Vasopressor-free days
Time frame: From randomisation to day 28 after randomisation
Ventilator-free days
Time frame: From randomisation to day 28 after randomisation
Therapy intensity level (TIL)
Time frame: At day 5 after randomisation
ICU and hospital mortality
Time frame: Hospital discharge
Neurological outcome (GOSE)
Time frame: Hospital discharge
Long-term mortality
Time frame: 180 days after randomization
Long-term neurological outcome (GOSE)
Time frame: 180 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 34302787Wiegers EJA, Lingsma HF, Huijben JA, Cooper DJ, Citerio G, Frisvold S, Helbok R, Maas AIR, Menon DK, Moore EM, Stocchetti N, Dippel DW, Steyerberg EW, van der Jagt M; CENTER-TBI; OzENTER-TBI Collaboration Groups. Fluid balance and outcome in critically ill patients with traumatic brain injury (CENTER-TBI and OzENTER-TBI): a prospective, multicentre, comparative effectiveness study. Lancet Neurol. 2021 Aug;20(8):627-638. doi: 10.1016/S1474-4422(21)00162-9.
- Background: PubMed 29500701Oddo M, Poole D, Helbok R, Meyfroidt G, Stocchetti N, Bouzat P, Cecconi M, Geeraerts T, Martin-Loeches I, Quintard H, Taccone FS, Geocadin RG, Hemphill C, Ichai C, Menon D, Payen JF, Perner A, Smith M, Suarez J, Videtta W, Zanier ER, Citerio G. Fluid therapy in neurointensive care patients: ESICM consensus and clinical practice recommendations. Intensive Care Med. 2018 Apr;44(4):449-463. doi: 10.1007/s00134-018-5086-z. Epub 2018 Mar 2.
- Background: PubMed 27654000Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
- Background: PubMed 36329266Messina A, Bakker J, Chew M, De Backer D, Hamzaoui O, Hernandez G, Myatra SN, Monnet X, Ostermann M, Pinsky M, Teboul JL, Cecconi M. Pathophysiology of fluid administration in critically ill patients. Intensive Care Med Exp. 2022 Nov 4;10(1):46. doi: 10.1186/s40635-022-00473-4.
- Background: PubMed 11940738Clifton GL, Miller ER, Choi SC, Levin HS. Fluid thresholds and outcome from severe brain injury. Crit Care Med. 2002 Apr;30(4):739-45. doi: 10.1097/00003246-200204000-00003.
- Results publication: PubMed 29253420Majdan M, Plancikova D, Brazinova A, Rusnak M, Nieboer D, Feigin V, Maas A. Epidemiology of traumatic brain injuries in Europe: a cross-sectional analysis. Lancet Public Health. 2016 Dec;1(2):e76-e83. doi: 10.1016/S2468-2667(16)30017-2. Epub 2016 Nov 29.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neutral Fluid Balance Strategy in people with Traumatic Brain Injury and Severe Traumatic Brain Injury, run by Erasme University Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Silvio Taccone, MD, PhD (+32 2 555 33 95, fabio.taccone@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of achieving a neutral daily fluid balance (time frame: At 5 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07625995, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.