Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.
Efficacy of Early Continuous Infusion of Hypertonic Saline Solution on the Neurological Outcome at 6 Months in Traumatic Brain Injured Patients. A Single-blinded, Multicenter, Randomized, Controlled Clinical Trial With Blinded Evaluation of the Primary Outcome.
Nantes University Hospital
760 participants
Apr 21, 2026
INTERVENTIONAL
Summary
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
Inclusion Criteria6
- 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
- Informed and signed consent
- National health insurance
Exclusion Criteria11
- 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
- Pregnancy (serum or urine test performed in routine care)
- Severe Cardiac insufficiency
- Severe chronic renal insufficiency
- Severe hepatic insufficiency: patient presenting with oedemato-ascitic decompensation of liver cirrhosis or patient with Child-Pugh class C cirrhosis
- High risk of follow-up difficulties after ICU discharge
- Patients under court protection
- Patient who does not speak French
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Interventions
Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
Locations(23)
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NCT07319208