NCT00319345

Sodium-Lactate and Traumatic Brain Injury

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 34 (planned)
• Sponsor: Institut d'Anesthesiologie des Alpes Maritimes · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Severe Trauma Brain Injury
• Intracranial Hypertension

Interventions

Type	Name	Description
DRUG	Mannitol, Sodium-Lactate

Timeline

• Start date: 2003-11-01
• Completion: 2005-11-01
• First posted: 2006-04-27
• Last updated: 2010-06-23

Locations

1 site across 1 country: France