Preventive Sodium Lactate and Traumatic Brain Injury
Condition: Head Trauma
MeSH terms: Brain Injuries; Intracranial Hypertension; Craniocerebral Trauma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of this study is to evaluate the effect of preventive intravenous infusion of half
      molar sodium lactate on the onset of hypertensive intracranial episodes in severe head
      trauma. The investigators hypothesize that preventive intravenous administration of sodium
      lactate will decrease the number of treatments required to decrease intracranial pressure
      during 48 hours.
    

Detailed description: 
      -  Intracranial hypertension is the most severe complication of severe head injury. This
           may lead to cerebral death or severe neurological outcome. To improve the prognosis of
           these patients,intracranial pressure must be maintained in normal range while
           maintaining cerebral perfusion pressure. Among numerous strategies, osmotherapy is
           frequently proposed to decrease intracranial pressure, using mannitol or hypertonic
           saline. Recently, it has been found that hypertonic sodium lactate infusion is more
           efficient to decrease intracranial hypertension compared with an equivalent volemic and
           osmotic mannitol administration.Thus, we hypothesized that a preventive sodium lactate
           infusion in severe head trauma could decrease the number of intracranial hypertensive
           episodes.

        -  Methods and Objectives : to compare in a randomized double-blind fashion two group of
           patients, i.e., those receiving a standard isotonic saline infusion (control group) with
           those receiving half-molar sodium lactate for 48 hours following admission in ICU. The
           primary endpoint is the number of any treatment required to control intracranial
           hypertensive episodes occurring during the first 48 hours following admission in ICU.
           Secondary endpoints are the effect of sodium lactate infusion on : intracranial pressure
           evolution;neurological outcome at 6 months (glasgow outcome scale); cerebral blood flow
           evaluated by transcranial doppler; and daily water balance

        -  Protocol consisted to measure as soon as possible baseline intracranial pressure and
           cerebral perfusion pressure, then immediately to begin the administration of 0.5 ml/kg/h
           intravenous isotonic saline perfusion or half-molar sodium lactate during 48 hours in a
           randomized double-blind fashion. Management of patients is the same for all patients.
           Treatment required for intracranial hypertensive episode is decided by a senior
           physician in charge of the patient. Sample size has been calculated considering that 50%
           of these patients will develop at least one intracranial hypertensive episode, each of
           them requiring at least 2 treatments. Based on previous results, we hypothesized that
           sodium lactate will decrease the number of required treatment by 2, leading to a sample
           size of 30 patients per group

        -  Follow up : 48 hours for treatments of intracranial hypertensive episodes; 6 months for
           the neurological outcome (glasgow outcome scale)
    

Intervention name(s): half molar sodium lactate; isotonic sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): intravenous infusion of 0.5 ml/kg during 48 hours; intravenous infusion of 0.5 ml/kg during 48 hours
Other intervention name(s): sodium lactate; sodium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: intracranial hypertension; neurological outcome; osmotherapy