NCT06110429

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intra Cerebral Hypertension
• Lactate Sodium Solution

Interventions

Type	Name	Description
DRUG	Lactate, Sodium	Isovolemic and osmotic infusion Comparison of osmotic agent
DRUG	Hypertonic saline	Isovolemic and osmotic infusion Comparison of osmotic agent

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-06-01
• Completion: 2026-01-01
• First posted: 2023-10-31
• Last updated: 2023-10-31