Preventive 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: Head Trauma
Intervention: half molar sodium lactate (Drug); isotonic sodium chloride (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Institut d'Anesthesiologie des Alpes Maritimes Official(s) and/or principal investigator(s): Carole Ichai, MD, PhD, Principal Investigator, Affiliation: Institut d'Anesthesiologie des Alpes Maritimes
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.
Clinical Details
Official title: Effect of Preventive Sodium Lactate Infusion on Intracranial Hypertension in Severe Trauma Tic Brain Injury
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: the number of treatments required for intracranial hypertensive episodes during the first 48 hours following ICU admission
Secondary outcome: the neurological outcome at six months evaluated by the glasgow outcome scale
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)
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- severe head trauma with a glasgow coma scale less than 9
Exclusion Criteria:
- prehospital cardiac arrest
- severe hemorrhage shock
- severe circulatory or respiratory failure
- medullar trauma
- prehospital osmotherapy
Locations and Contacts
Institut d'Anesthesiologie des Alpes maritimes, Nice 06000, France
Additional Information
Starting date: June 2009
Last updated: July 9, 2011
|