Traumatic Brain InjuryLIMITNCT05983549
Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial
A study testing fluid balance in people with Traumatic Brain Injury and Fluid Overload, run by Universita degli Studi di Genova.
Trial summary
Feasibility and safety of targeting neutral vs liberal fluid balance in traumatic brain injured patients: a phase II randomized controlled trial Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Brain Injury, Fluid Overload, Outcome, Fatal
- What is being tested?
- fluid balance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients with TBI (isolated or with extracranial injuries, with and without ICP monitoring)
- Admitted to intensive care unit
- Age >18 years
- Enrolment <48h after ICU admission
Who cannot join
- Enrolled in another clinical trial that is unapproved for co-enrolment
- Pregnant or suspected pregnancy
- Concomitant hemorrhagic shock expected to require surgical treatment in the following 24h from inclusion or requiring polytransfusions (> 6 blood products or massive transfusion protocol)
- Hemodynamic instability (HR > 120 despite fluid resuscitation of at least 1 liter, and systolic blood pressure < 90 mmHg) at the ICU admission requiring high dosage of norepinephrine (> 0.5 mcg/kg/min) or inotropes (any dose)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Neutral Versus Liberal fLuId Balance In TraumaTic Brain Injury: a Randomised Phase II Feasibility Controlled Trial
Feasibility and safety of targeting neutral vs liberal fluid balance in traumatic brain injured patients: a phase II randomized controlled trial
Read the detailed description
To determine whether a zero fluid balance strategy during the first week compared to a more liberal fluid policy (allowing positive balance) is feasible in adult intensive care unit (ICU) patients with traumatic brain injury (TBI).Participants randomized to neutral fluid balance will be assessed daily with the aim to maintain a mean daily fluid balance of 0 over the course of the first 5 days from randomization (maximum at day 7 of ICU stay). In case of need for augmentation of cerebral perfusion pressure with 0 balance, fluids will be allowed according to a predefined protocol (see further).Participants randomized to the control group will receive the standard fluid management required as determined by the treating team. Fluid strategy as randomised should be applied for at least 5 days from randomization.
Primary aim: ● Feasibility: ability to achieve a daily neutral balance (0 +/- 500 ml) in the intervention group.
Secondary aims:● Incidence of renal complications, including acute kidney injury, need for renal replacement, multiorgan failure
- Respiratory complications including reduced partial pressure of oxygen/ fraction of inspired oxygen (P/F) ratio
- Cardiopulmonary complications, i.e myocardial infarction, cardiac failure, cardiac arrhythmias, ventricular or supraventricular, pulmonary oedema, ventilator associated pneumonia, acute respiratory distress syndrome
- Difference in mean and daily CPP among the groups
- Difference in daily fluid balance and fluid input during the first 7 days after ICU admission
- Total and daily dose of vasopressors and diuretics during ICU stay
- Vasopressor-free days up to 28 days from ICU admission
- ICU-free days up to 28 days
- Ventilator-free days up to 28 days from intubation.
- Maximum Therapy intensity level (TIL) during the 5 days of randomization
- Conditions
- Traumatic Brain Injury, Fluid Overload, Outcome, Fatal
- Being tested
- fluid balance
- Medical subject headings
- Brain Injuries, Traumatic, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid balanceProcedure or surgery
patients will receive fluids with the aim to achieve a neutral balance
| Study group | Role | What they receive |
|---|---|---|
| Standard of care group | No intervention | Patients will receive fluids according to clinical practice |
| Neutral balance | Active comparator | Patients will receive fluids aiming to a neutral balance Receives: Procedure: fluid balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- rate of patients able to achieve neutral fluid balance( 0 +/- 500 ml) during the first week from ICU admission
Ability to target and achieve a daily and total neutral fluid balance (0 +/- 500 ml) in the intervention group. In particular,testing the hypothesis of whether all pairwise differences between group means are the same in a design of repeated measures with 7 days points. We hypothesise a mean of 0 ml in the conservative group, a mean of 1000 ml in the liberal group and standard deviation in the population of 850 ml (500 ml in the conservative group and 1000 ml in the liberal group)
Measured: 7 days
Secondary outcomes (2)
Safety to achieve neutral balance, i.e. the estimation of the difference of incidence of renal, pulmonary, cardiac complications between the two arms
Complications occurring during the ICU stay
Measured: From date of randomization until the date of intensive care unit discharge or death assessed up to 6 months
Rates of patients who die and experience poor neurological outcome after 6 months from ICU admission
at 6 months, at hospital and ICU discharge
Measured: 6 months from ICU admission and enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi di Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Robba, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983549
- Sponsor's protocol ID
- 001
- Acronym
- LIMIT
- Status last verified
- Aug 2023
- First submitted
- 12 Jul 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neutral Versus Liberal fLuId Balance In TraumaTic Brain Injury: a Randomised Phase II Feasibility Controlled Trial
- ClinicalTrials.gov ID
- NCT05983549
- Acronym / sponsor ID
- LIMIT / 001
- Conditions
- Traumatic Brain Injury, Fluid Overload, Outcome, Fatal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 9 Aug 2023 (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.
Feasibility and safety of targeting neutral vs liberal fluid balance in traumatic brain injured patients: a phase II randomized controlled trial
Detailed description
To determine whether a zero fluid balance strategy during the first week compared to a more liberal fluid policy (allowing positive balance) is feasible in adult intensive care unit (ICU) patients with traumatic brain injury (TBI).Participants randomized to neutral fluid balance will be assessed daily with the aim to maintain a mean daily fluid balance of 0 over the course of the first 5 days from randomization (maximum at day 7 of ICU stay). In case of need for augmentation of cerebral perfusion pressure with 0 balance, fluids will be allowed according to a predefined protocol (see further).Participants randomized to the control group will receive the standard fluid management required as determined by the treating team. Fluid strategy as randomised should be applied for at least 5 days from randomization.
Primary aim: ● Feasibility: ability to achieve a daily neutral balance (0 +/- 500 ml) in the intervention group.
Secondary aims:● Incidence of renal complications, including acute kidney injury, need for renal replacement, multiorgan failure
- Respiratory complications including reduced partial pressure of oxygen/ fraction of inspired oxygen (P/F) ratio
- Cardiopulmonary complications, i.e myocardial infarction, cardiac failure, cardiac arrhythmias, ventricular or supraventricular, pulmonary oedema, ventilator associated pneumonia, acute respiratory distress syndrome
- Difference in mean and daily CPP among the groups
- Difference in daily fluid balance and fluid input during the first 7 days after ICU admission
- Total and daily dose of vasopressors and diuretics during ICU stay
- Vasopressor-free days up to 28 days from ICU admission
- ICU-free days up to 28 days
- Ventilator-free days up to 28 days from intubation.
- Maximum Therapy intensity level (TIL) during the 5 days of randomization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care group | No intervention | –Patients will receive fluids according to clinical practice |
| Neutral balance | Active comparator | Procedure: fluid balancePatients will receive fluids aiming to a neutral balance |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with TBI (isolated or with extracranial injuries, with and without ICP monitoring)
- Admitted to intensive care unit
- Age >18 years
- Enrolment <48h after ICU admission
Key exclusion criteria (4 listed)
- Enrolled in another clinical trial that is unapproved for co-enrolment
- Pregnant or suspected pregnancy
- Concomitant hemorrhagic shock expected to require surgical treatment in the following 24h from inclusion or requiring polytransfusions (> 6 blood products or massive transfusion protocol)
- Hemodynamic instability (HR > 120 despite fluid resuscitation of at least 1 liter, and systolic blood pressure < 90 mmHg) at the ICU admission requiring high dosage of norepinephrine (> 0.5 mcg/kg/min) or inotropes (any dose)
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 |
|---|---|---|
| fluid balancepatients will receive fluids with the aim to achieve a neutral balance | Procedure or surgery | Neutral balance |
Primary outcome
Feasibility- rate of patients able to achieve neutral fluid balance( 0 +/- 500 ml) during the first week from ICU admission
Time frame: 7 days
Ability to target and achieve a daily and total neutral fluid balance (0 +/- 500 ml) in the intervention group. In particular,testing the hypothesis of whether all pairwise differences between group means are the same in a design of repeated measures with 7 days points. We hypothesise a mean of 0 ml in the conservative group, a mean of 1000 ml in the liberal group and standard deviation in the population of 850 ml (500 ml in the conservative group and 1000 ml in the liberal group)
2 secondary outcomes
Safety to achieve neutral balance, i.e. the estimation of the difference of incidence of renal, pulmonary, cardiac complications between the two arms
Time frame: From date of randomization until the date of intensive care unit discharge or death assessed up to 6 months
Rates of patients who die and experience poor neurological outcome after 6 months from ICU admission
Time frame: 6 months from ICU admission and enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: Yes. IPD will be available
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing fluid balance in people with Traumatic Brain Injury and Fluid Overload, run by Universita degli Studi di Genova.
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 4 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: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiara Robba, PhD (3473912338, kiarobba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility- rate of patients able to achieve neutral fluid balance( 0 +/- 500 ml) during the first week from ICU admission (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2023.