Sodium-Lactate and Traumatic Brain Injury

• Status: Terminated
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut d'Anesthesiologie des Alpes Maritimes
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; PT Kalbe Farma TBK
• Treatments: Mannitol

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