Intra Cerebral Hypertension, Lactate Sodium Solution
Conditions
Keywords
intracerebral hypertension, lactate sodium
Brief summary
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.
Interventions
DRUGLactate, Sodium
Isovolemic and osmotic infusion Comparison of osmotic agent
DRUGHypertonic saline
Isovolemic and osmotic infusion Comparison of osmotic agent
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
A prospective open randomized single center study comparing Sodium lactate (SL) to Hypertonic Saline Solution (HSS) in brain injured adult ICU
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient with an acute, isolated, severe brain injury (SAH, TBI, ICH) * Glasgow coma score \<8 * Monitored using ICP device * Presenting an episode of intracranial hypertension requiring osmotherapy. ( defined as increase in ICP 25 mmHg which persisted for more than 5 min in the absence of noxious stimulations) * Informed Consent as documented by signature
Exclusion criteria
* Pregnant woman * Bilateral fixed dilatated pupils * Initial hypernatremia (\>155 mmol/l) * Penetrating head injury * Active participation to another trial (Clin B, C)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intracranial pressure (ICP) | 240 minutes | Invasive monitoring of intracranial pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of successfully treated episodes | 48 hours | decrease of ICP \>5mmHg or level \<20mmHg |
| Oxygen tissular pressure | 240 minutes | In vasive measurement of tissular pressure |
| Neurological status at discharge of ICU | through study completion, an average of 30 days | Measurement Glasgow Outcome Scale |
| Number of episodes of intracranial hypertension | through study completion, an average of 30 days | Number of episodes of intracranial hypertension |
Contacts
Primary ContactHerve Quintard, MD, PhD
Backup Contactaurélie Perret
Outcome results
None listed