Brain oedema is a major complication of brain injury (TBI). It increases the risk of intracranial hypertension (ICH) and brain hypoxia, leading to an increase in mortality and poor neurologic outcome. Increased water content in the injured brain can be related to a vasogenic or cellular pathway. Osmotherapy, by using mannitol or hypertonic saline (HSS), is recommended and currently administered for the treatment of ICH in this setting. Beside these two usual treatments, sodium lactate (SL), a metabolic and neuroprotective solution, has recently been described as having similar effects on lowering intracranial pressure (ICP). In a previous study, conducted in patients with severe TBI, (1) Ichai et al. reported that a bolus of half-molar SL was as effective than equimolar doses of mannitol to reduce elevated ICP (less refractory ICH and higher and longer reduction of ICH). Objective(s): The purpose of the study is to analyze the effect on ICH of SL compared to a hypertonic saline solution (HSS). Outcome(s): The primary endpoint is the efficacy in lowering ICH after 4 h. Secondary endpoints were percentage of successfully treated episodes of intracranial hypertension and neurological status at discharge from ICU.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
Isovolemic and osmotic infusion Comparison of osmotic agent
Isovolemic and osmotic infusion Comparison of osmotic agent
intracranial pressure (ICP)
Invasive monitoring of intracranial pressure
Time frame: 240 minutes
Percentage of successfully treated episodes
decrease of ICP \>5mmHg or level \<20mmHg
Time frame: 48 hours
Oxygen tissular pressure
In vasive measurement of tissular pressure
Time frame: 240 minutes
Neurological status at discharge of ICU
Measurement Glasgow Outcome Scale
Time frame: through study completion, an average of 30 days
Number of episodes of intracranial hypertension
Number of episodes of intracranial hypertension
Time frame: through study completion, an average of 30 days
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