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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
History of Changes
  Purpose

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 Intervention Phase
Severe Trauma Brain Injury
Intracranial Hypertension
 Drug: Mannitol, Sodium-Lactate
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut d'Anesthesiologie des Alpes Maritimes:

Primary Outcome Measures:
  • Efficiency to decrease ICP during IHE episodes

Secondary Outcome Measures:
  • Number of successful treatment, neurological status (Glasgow outcome score) after one year of evolution

Estimated Enrollment: 34
Study Start Date: November 2003
Estimated Study Completion Date: November 2005
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319345

Locations
France
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00319345     History of Changes
Other Study ID Numbers: CHUN-LM-0001
Study First Received: April 27, 2006
Last Updated: June 22, 2010
Health Authority: France: Institutional Ethical Committee

Keywords provided by Institut d'Anesthesiologie des Alpes Maritimes:
Traumatic brain injury
Intracranial pressure
Osmotherapy
 Glasgow outcome score
Mannitol
Sodium-Lactate

Additional relevant MeSH terms:
Hypertension
Intracranial Hypertension
Brain Injuries
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
 Wounds and Injuries
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013