Status:
UNKNOWN
Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial
Lead Sponsor:
Universita degli Studi di Genova
Conditions:
Traumatic Brain Injury
Fluid Overload
Eligibility:
All Genders
16+ years
Phase:
NA
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05983549
Start Date
September 1 2023
End Date
September 1 2025
Last Update
August 9 2023
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