Sodium-Lactate and Traumatic Brain Injury

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of bolus of either sodium-lactate or mannitol on the evolution of intracranial pressure (ICP) during intracranial hypertensive episodes (IHE)

Detailed Description
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Osmotherapy with mannitol remains the first treatment currently recommended to treat intracranial hypertension in severe head injury.However, this treatment in not always efficient and is associated with side-effects and a transitory action. Hypertonic sodium-lactate, by its osmotic and energetic properties could be superior to mannitol to decrease ICP. Study objectives : to compare the effect of mannitol and sodium-lactate on ICP at the fourth hour after the start of infusion during IHE in severe traumatic brain injury (TBI) (main endpoint) ; to compare the percentage of successfully treated episodes between both treatments and to compare the neurological status after one year of evolution (glasgow outcome score)(secondary endpoints) Patients inclusion : adult severe TBI (glasgow coma score < 9) < 66 yrs Exclusion criteria : polytrauma, bilateral fixed dilated pupils, motor score < 4, neurosurgery, prolonged episode of hypoxia or arterial hypotension, 34 patients included from november 2003 to november 2004 and randomized into two groups : MAN group receiving mannitol 20% 100 ml in 15 min (17 patients, 36 episodes of IHE treated) and LAC group receiving semimolar sodium-lactate 100 ml in 15 min (17 patients, 37 episodes of IHE treated). For ethical reasons a rescue treatment in a crossover fashion was performed for each episode of IHE when the randomized treatment failed. Follow-up : one year after the TBI. Study end : november 30, 2005

Official Title
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Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients

Conditions
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Severe Trauma Brain Injury, Intracranial Hypertension

Intervention / Treatment
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* Drug: Mannitol, Sodium-Lactate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 65 years severe traumatic brain injury prehospital glasgow coma scale < 9 rapid neurological worsening before admission Exclusion Criteria: neurosurgical intervention polytrauma bilatéral fixed dilated pupils motorscore < 4 prolonged episode of hypoxia or arterial hypotension abundant rinorrhea

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mannitol, Sodium-Lactate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficiency to decrease ICP during IHE episodes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successful treatment, neurological status (Glasgow outcome score) after one year of evolution |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury, Intracranial pressure, Osmotherapy, Glasgow outcome score, Mannitol, Sodium-Lactate