Sodium-Lactate and Traumatic Brain Injury

Phase 2

Terminated

• Conditions: Intracranial Hypertension; Severe Trauma Brain Injury

• Registration Number: NCT00319345
• Lead Sponsor: Institut d'Anesthesiologie des Alpes Maritimes

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 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

Study Timeline

• Study Start: 2003-11
• Study Completion: 2005-11
• Status Verified: 2006-04
• Study First Submitted: 2006-04-27
• Study First Submitted QC: 2006-04-27
• Study First Posted: 2006-04-27
• Last Update Submitted: 2010-06-22
• Last Update Posted: 2010-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Efficiency to decrease ICP during IHE episodes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, Alpes Maritimes, France