TBI Traumatic Brain Injury
Conditions
Keywords
Traumatic brain injury, Saline Solution, Hypertonic
Brief 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.
Interventions
Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Controlled, Single insulated with blinded assessment of the primary endpoint, Prospective
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of early continuous of HSS | 3 months | Survival : number of patients still alive |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological recovery | 7 days | Number of therapeutic interventions with the TIL (Therapeutic Intensity Level) scale. |
| Quality of life | until 12 month | Score of EQ-5D-5L (5-level EuroQol-5D version) : minimum - maximal values: 1-5, higher scores mean a worse outcome. |
| Anterograde amnesia | until 6 months | Galveston Orientation and Amnesia Test (G.O.A.T) : minimum - maximal values: 0-100, higher scores mean a better outcome. |
| Neurocognitive functioning | 6 months | Montreal Cognitive Assessment (MOCA) : minimum - maximal values: 0-30, higher scores mean a better outcome. |
| Treatment of intracranial hypertension | 7 days | Evolution of blood sodium level |
| Tolerance | 1 month | Rates severe hypernatremia (Na\> 160 mmol/L) |
| Cost-effectiveness analysis | 12 months | Incremental cost-effectiveness ratio |
| Genetic biomarkers | 12 months | Single nucleotide polymorphism |
| Neurological outcome | 6 months | Glasgow Outcome Scale Extended (GOS-E) : minimum - maximal values: 1-8, higher scores mean a better outcome. |
Countries
France
Contacts
Primary ContactAntoine ROQUILLY
Backup ContactAstrid GARREAU
Outcome results
None listed