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

NCT06110429 — Phase 3, Unknown, 52 participants, University Hospital, Geneva

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT06110429, acronym SLHYSS
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	52 (Estimated)
Sponsor	University Hospital, Geneva (Other)
Conditions	Intra Cerebral Hypertension, Lactate Sodium Solution
Interventions	Lactate, Sodium, Hypertonic saline (Drug)
Dates	start 2024-01-01 (estimated), primary completion 2025-06-01 (estimated), completion 2026-01-01 (estimated), first posted 2023-10-31, last updated 2023-10-31

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
lactate sodium	Experimental	Drug: Lactate, Sodium	100 mL of Sodium lactate (Osmolality 2560 mOsm/L) in 15 mins of administration via a central venous catheter
Hypertonic Saline solution	Active comparator	Drug: Hypertonic saline	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

Lactate, Sodium (Drug): Isovolemic and osmotic infusion Comparison of osmotic agent
Hypertonic saline (Drug): Isovolemic and osmotic infusion Comparison of osmotic agent

+Outcome measures

Primary outcomes

intracranial pressure (ICP) [240 minutes]: Invasive monitoring of intracranial pressure

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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)