Sodium-Lactate and Traumatic Brain Injury
Information source: Institut d'Anesthesiologie des Alpes Maritimes
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Severe Trauma Brain Injury; Intracranial Hypertension
Intervention: Mannitol, Sodium-Lactate (Drug)
Phase: Phase 2/Phase 3
Status: Terminated
Sponsored by: Institut d'Anesthesiologie des Alpes Maritimes Official(s) and/or principal investigator(s): Carole R ICHAI, MD-PhD, Study Director
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)
Clinical Details
Official title: Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment
Primary outcome: Efficiency to decrease ICP during IHE episodes
Secondary outcome: Number of successful treatment, neurological status (Glasgow outcome score) after one year of evolution
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
CHU de Nice, Nice, Alpes Maritimes 06006, France
Additional Information
Starting date: November 2003
Last updated: June 22, 2010
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