Sodium-Lactate and Traumatic Brain Injury

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00319345
• Date of registration: 27/04/2006
• Prospective Registration: No
• Primary sponsor: Institut d'Anesthesiologie des Alpes Maritimes
• Public title: Sodium-Lactate and Traumatic Brain Injury
• Scientific title: Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients
• Date of first enrolment: November 2003
• Target sample size: 34
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00319345
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Contacts

• Name: Carole R ICHAI, MD-PhD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Severe Trauma Brain Injury

Intracranial Hypertension

Intervention(s)

Drug: Mannitol, Sodium-Lactate

Primary Outcome(s)

Efficiency to decrease ICP during IHE episodes

Secondary Outcome(s)

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

Secondary ID(s)

CHUN-LM-0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PT Kalbe Farma TBK

Institut National de la Santé Et de la Recherche Médicale, France