Clinical trial NCT05983549: Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial
Official title: The Effect of Neutral Versus Liberal fLuId Balance In TraumaTic Brain Injury: a Randomised Phase II Feasibility Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Fluid Overload
Outcome, Fatal
Lead sponsor: Universita degli Studi di Genova
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Feasibility- rate of patients able to achieve neutral fluid balance( 0 +/- 500 ml) during the first week from ICU admission
timeFrame: 7 days
Secondary outcomes:
measure: Safety to achieve neutral balance, i.e. the estimation of the difference of incidence of renal, pulmonary, cardiac complications between the two arms
timeFrame: From date of randomization until the date of intensive care unit discharge or death assessed up to 6 months
measure: Rates of patients who die and experience poor neurological outcome after 6 months from ICU admission
timeFrame: 6 months from ICU admission and enrolment
Other outcomes:
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