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Sodium-Lactate and Traumatic Brain Injury

Sponsor
Institut d'Anesthesiologie des Alpes Maritimes (Other)
Overall Status
Terminated
CT.gov ID
NCT00319345
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other), PT Kalbe Farma TBK (Other)
34
Enrollment
1
Location
24
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Drug: Mannitol, Sodium-Lactate
 Phase 2/Phase 3

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

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients
Study Start Date :
Nov 1, 2003
Study Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Efficiency to decrease ICP during IHE episodes []

Secondary Outcome Measures

  1. Number of successful treatment, neurological status (Glasgow outcome score) after one year of evolution []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nice Nice Alpes Maritimes France 06006

Sponsors and Collaborators

  • Institut d'Anesthesiologie des Alpes Maritimes
  • Institut National de la Santé Et de la Recherche Médicale, France
  • PT Kalbe Farma TBK

Investigators

  • Study Director: Carole R ICHAI, MD-PhD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00319345
Other Study ID Numbers:
  • CHUN-LM-0001
First Posted:
Apr 27, 2006
Last Update Posted:
Jun 23, 2010
Last Verified:
Apr 1, 2006
Keywords provided by , ,
Traumatic brain injury
Intracranial pressure
Osmotherapy
Glasgow outcome score
Mannitol
Sodium-Lactate
Additional relevant MeSH terms:
Brain Injuries
Intracranial Hypertension
Mannitol

Study Results

No Results Posted as of Jun 23, 2010