Status:
TERMINATED
Sodium-Lactate and Traumatic Brain Injury
Lead Sponsor:
Institut d'Anesthesiologie des Alpes Maritimes
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
PT Kalbe Farma Tbk
Conditions:
Severe Trauma Brain Injury
Intracranial Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 w...
Eligibility Criteria
Inclusion
- age between 18 and 65 years
- severe traumatic brain injury
- prehospital glasgow coma scale \< 9
- rapid neurological worsening before admission
Exclusion
- neurosurgical intervention
- polytrauma
- bilatéral fixed dilated pupils
- motorscore \< 4
- prolonged episode of hypoxia or arterial hypotension
- abundant rinorrhea
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00319345
Start Date
November 1 2003
End Date
November 1 2005
Last Update
June 23 2010
Active Locations (1)
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1
CHU de Nice
Nice, Alpes Maritimes, France, 06006