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

University Hospitals (UH)

Status and phase: Not yet enrolling; Phase 3

Conditions: Intra Cerebral Hypertension; Lactate Sodium Solution

Treatments: Drug: Hypertonic saline; Drug: Lactate, Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT06110429

701546

Details and patient eligibility

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: 52 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

lactate sodium

Experimental group

Description:

100 mL of Sodium lactate (Osmolality 2560 mOsm/L) in 15 mins of administration via a central venous catheter

Treatment:

Drug: Lactate, Sodium

Hypertonic Saline solution

Active Comparator group

Description:

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

Treatment:

Drug: Hypertonic saline