Clinical trial NCT06110429: Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients
Official title: Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Intra Cerebral Hypertension
Lactate Sodium Solution
Keywords: intracerebral hypertension
lactate sodium
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective open randomized single center study comparing Sodium lactate (SL) to Hypertonic Saline Solution (HSS) in brain injured adult ICU
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: intracranial pressure (ICP)
timeFrame: 240 minutes
Secondary outcomes:
measure: Percentage of successfully treated episodes
timeFrame: 48 hours
measure: Oxygen tissular pressure
timeFrame: 240 minutes
measure: Neurological status at discharge of ICU
timeFrame: through study completion, an average of 30 days
measure: Number of episodes of intracranial hypertension
timeFrame: through study completion, an average of 30 days
Other outcomes:
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