Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients

Study Overview
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Brief Summary
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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.

Official Title
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Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients

Conditions
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Intra Cerebral Hypertension, Lactate Sodium Solution

Intervention / Treatment
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* Drug: Lactate, Sodium
* Drug: Hypertonic saline


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective open randomized single center study comparing Sodium lactate (SL) to Hypertonic Saline Solution (HSS) in brain injured adult ICU
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lactate sodium<br>100 mL of Sodium lactate (Osmolality 2560 mOsm/L) in 15 mins of administration via a central venous catheter | Drug: Lactate, Sodium<br>* Isovolemic and osmotic infusion Comparison of osmotic agent<br>|
| Active Comparator: Hypertonic Saline solution<br>single infusion of 100 mL of 7.5% saline (osmolarity, 2560 mOsm/L) (HSS group)in 15 mins of administration via a central venous catheter | Drug: Hypertonic saline<br>* Isovolemic and osmotic infusion Comparison of osmotic agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intracranial pressure (ICP) | Invasive monitoring of intracranial pressure | 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of successfully treated episodes | decrease of ICP >5mmHg or level <20mmHg | 48 hours | 
| Oxygen tissular pressure | In vasive measurement of tissular pressure | 240 minutes | 
| Neurological status at discharge of ICU | Measurement Glasgow Outcome Scale | through study completion, an average of 30 days | 
| Number of episodes of intracranial hypertension | Number of episodes of intracranial hypertension | through study completion, an average of 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracerebral hypertension, lactate sodium