Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial (NCT05983549) | Clinical Trial Compass
UnknownNot Applicable
Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial
80 participantsStarted 2023-09-01
Plain-language summary
Feasibility and safety of targeting neutral vs liberal fluid balance in traumatic brain injured patients: a phase II randomized controlled trial
Who can participate
Age range16 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Feasibility- rate of patients able to achieve neutral fluid balance( 0 +/- 500 ml) during the first week from ICU admission