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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intra Cerebral Hypertension; Lactate Sodium Solution
• Intervention / Treatment: Drug: Lactate, Sodium; Drug: Hypertonic saline

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Herve Quintard, MD, PhD; Phone Number: +41795532188; Email: herve.quintard@hcuge.ch
• Study Contact Backup: Name: aurélie Perret; Phone Number: +41795530805; Email: aurelie.perret@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lactate sodium; 100 mL of Sodium lactate (Osmolality 2560 mOsm/L) in 15 mins of administration via a central venous catheter	Drug: Lactate, Sodium; Isovolemic and osmotic infusion Comparison of osmotic agent
Active Comparator: Hypertonic Saline solution; 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; Isovolemic and osmotic infusion Comparison of osmotic agent

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: intracerebral hypertension; lactate sodium
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 701546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No