Sodium-Lactate and Traumatic Brain Injury

This study has been terminated.
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
PT Kalbe Farma TBK
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes
ClinicalTrials.gov Identifier:
NCT00319345
First received: April 27, 2006
Last updated: June 22, 2010
Last verified: April 2006

April 27, 2006
June 22, 2010
November 2003
Not Provided
Efficiency to decrease ICP during IHE episodes
Same as current
Complete list of historical versions of study NCT00319345 on ClinicalTrials.gov Archive Site
Number of successful treatment, neurological status (Glasgow outcome score) after one year of evolution
Same as current
Not Provided
Not Provided
 
Sodium-Lactate and Traumatic Brain Injury
Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Severe Trauma Brain Injury
  • Intracranial Hypertension
Drug: Mannitol, Sodium-Lactate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
November 2005
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00319345
CHUN-LM-0001
Not Provided
Not Provided
Institut d'Anesthesiologie des Alpes Maritimes
  • Institut National de la Santé Et de la Recherche Médicale, France
  • PT Kalbe Farma TBK
Study Director: Carole R ICHAI, MD-PhD
Institut d'Anesthesiologie des Alpes Maritimes
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP