About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient admitted to intensive care unit
Traumatic brain injury with Glasgow Coma Scale ≤ 12
Intracranial pressure (ICP) monitoring based on the attending physician's clinical judgment, in accordance with guidelines or clinical/radiological signs considered at risk of intracranial hypertension
Inclusion during the first 12 hours after Intracranial pressure monitoring placement
Disqualifiers
Glasgow Coma Scale (score = 3) and persistent abnormal pupillaryreactivity despite urgent therapy
Associated cervical spinal cord injury
Imminent death and do-not-resuscitate orders
Coma secondary to cardiac arrest
Trial design
Parallel
Treatments tested in this trial
Hypertonic saline solution
DrugContinuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
Treatment groups
Trial outcomes
Primary outcomes
Efficacy of early continuous of HSS
Survival : number of patients still alive
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.
Secondary outcomes
Treatment of intracranial hypertension
Evolution of blood sodium level
Treatment of intracranial hypertension
Evolution of blood chloride level
Treatment of intracranial hypertension
Evolution of solute concentration in blood plasma
Neurological recovery
Number of therapeutic interventions with the TIL (Therapeutic Intensity Level) scale.
Sponsors and contacts
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