Overview

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