Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial (LIMIT)

University of Genoa (UniGe)

Status

Not yet enrolling

Conditions

Traumatic Brain Injury

Fluid Overload

Outcome, Fatal

Treatments

Procedure: fluid balance

Study type

Interventional

Funder types

Other

Identifiers

NCT05983549

001

Details and patient eligibility

About

Feasibility and safety of targeting neutral vs liberal fluid balance in traumatic brain injured patients: a phase II randomized controlled trial

Full 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

Enrollment

80 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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)