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Sodium-Lactate and Traumatic Brain Injury

Information source: Institut d'Anesthesiologie des Alpes Maritimes
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Severe Trauma Brain Injury; Intracranial Hypertension

Intervention: Mannitol, Sodium-Lactate (Drug)

Phase: Phase 2/Phase 3

Status: Terminated

Sponsored by: Institut d'Anesthesiologie des Alpes Maritimes

Official(s) and/or principal investigator(s):
Carole R ICHAI, MD-PhD, Study Director

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)

Clinical Details

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

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

Primary outcome: Efficiency to decrease ICP during IHE episodes

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

CHU de Nice, Nice, Alpes Maritimes 06006, France
Additional Information

Starting date: November 2003
Last updated: June 22, 2010

Page last updated: August 23, 2015

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