The purpose of this study is to demonstrate the efficacy of early continuous intravenous infusion of hypertonic saline solution (HSS) to improve survival and independence in daily life activities (at 6 months) of patients with traumatic brain injury at high risk of intracranial hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
760
Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
CHU d'Angers
Angers, France
NOT_YET_RECRUITINGCHU de Brest
Efficacy of early continuous of HSS
Survival : number of patients still alive
Time frame: 3 months
Efficacy of early continuous of HSS
Rate of moderate to no dependency in activities in daily living at 6 months is defined as a Barthel Index of independence in activities in daily living ≥ 61.
Time frame: 6 months
Treatment of intracranial hypertension
Evolution of blood sodium level
Time frame: 7 days
Treatment of intracranial hypertension
Evolution of blood chloride level
Time frame: 7 days
Treatment of intracranial hypertension
Evolution of solute concentration in blood plasma
Time frame: 7 days
Neurological recovery
Number of therapeutic interventions with the TIL (Therapeutic Intensity Level) scale.
Time frame: 7 days
Neurological recovery
Survival : number of patients still alive
Time frame: until 12 months
Quality of life
Score of EQ-5D-5L (5-level EuroQol-5D version) : minimum - maximal values: 1-5, higher scores mean a worse outcome.
Time frame: until 12 month
Quality of life
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Brest, France
CHU Caen Normandie
Caen, France
RECRUITINGCHU de Clermont- Ferrand
Clermont-Ferrand, France
RECRUITINGHôpital BEAUJON APHP
Clichy, France
RECRUITINGCHU Henri Mondor APHP
Créteil, France
RECRUITINGCH de Annecy Genevois
Épagny, France
NOT_YET_RECRUITINGCHU de Grenoble
Grenoble, France
NOT_YET_RECRUITINGCHU de Lille
Lille, France
RECRUITINGHCL
Lyon, France
NOT_YET_RECRUITING...and 13 more locations
Rates of patient living at home, at rehabilitation centers or at hospital
Time frame: until 12 months
Anterograde amnesia
Galveston Orientation and Amnesia Test (G.O.A.T) : minimum - maximal values: 0-100, higher scores mean a better outcome.
Time frame: until 6 months
Neurocognitive functioning
Montreal Cognitive Assessment (MOCA) : minimum - maximal values: 0-30, higher scores mean a better outcome.
Time frame: 6 months
Neurological outcome
Glasgow Outcome Scale Extended (GOS-E) : minimum - maximal values: 1-8, higher scores mean a better outcome.
Time frame: 6 months
Tolerance
Rates severe hypernatremia (Na\> 160 mmol/L)
Time frame: 1 month
Tolerance
Rates of acute kidney injury
Time frame: 1 month
Tolerance
Number of thrombotic events
Time frame: 1 month
Tolerance
Number of entral-pontine myelinolysis
Time frame: 1 month
Cost-effectiveness analysis
Incremental cost-effectiveness ratio
Time frame: 12 months
Genetic biomarkers
Single nucleotide polymorphism
Time frame: 12 months