Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
52 participants in 2 patient groups
Loading...
Central trial contact
aurélie Perret; Herve Quintard, MD, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal