Sodium-Lactate and Traumatic Brain Injury

Intracranial Hypertension Clinical Trial

Official title:

Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00319345
• Other study ID #: CHUN-LM-0001
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 27, 2006
• Last updated: June 22, 2010
• Start date: November 2003
• Est. completion date: November 2005

Study information

• Verified date: April 2006
• Source: Institut d'Anesthesiologie des Alpes Maritimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Intracranial Hypertension
• Severe Trauma Brain Injury

Intervention

Drug:
• Mannitol, Sodium-Lactate

Locations

Country	Name	City	State
France	CHU de Nice	Nice	Alpes Maritimes

Sponsors (3)

Lead Sponsor	Collaborator
Institut d'Anesthesiologie des Alpes Maritimes	Institut National de la Santé Et de la Recherche Médicale, France, PT Kalbe Farma TBK

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficiency to decrease ICP during IHE episodes
Secondary	Number of successful treatment, neurological status (Glasgow outcome score) after one year of evolution