Clinical trial NCT00319345: Sodium-Lactate and Traumatic Brain Injury
Official title: Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Severe Trauma Brain Injury
Intracranial Hypertension
Keywords: Traumatic brain injury
Intracranial pressure
Osmotherapy
Glasgow outcome score
Mannitol
Sodium-Lactate
Lead sponsor: Institut d'Anesthesiologie des Alpes Maritimes
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: PT Kalbe Farma Tbk
First posted: 2006-04-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Eligibility 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

Primary outcomes:
measure: Efficiency to decrease ICP during IHE episodes
Secondary outcomes:
measure: Number of successful treatment, neurological status (Glasgow outcome score) after one year of evolution
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes Maritimes
Study officials:
name: Carole R ICHAI, MD-PhD
role: STUDY_DIRECTOR
References: