Trial | NCT00319345  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    34
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)
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
Study Started
Nov 30
2003
Study Completion
Nov 30
2005
Last Update
Jun 23
2010
Estimate

Drug Mannitol, Sodium-Lactate

Criteria 

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
No Results Posted