Traumatic Brain Injury Clinical Trial
— LIMITOfficial 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
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | September 1, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Universita degli Studi di Genova |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 7 days | |
Secondary | 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 | From date of randomization until the date of intensive care unit discharge or death assessed up to 6 months | |
Secondary | Rates of patients who die and experience poor neurological outcome after 6 months from ICU admission | at 6 months, at hospital and ICU discharge | 6 months from ICU admission and enrolment |
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