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

Sponsor

University Hospital, Geneva (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06110429

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intra Cerebral Hypertension Lactate Sodium Solution	Drug: Lactate, Sodium Drug: Hypertonic saline	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A prospective open randomized single center study comparing Sodium lactate (SL) to Hypertonic Saline Solution (HSS) in brain injured adult ICUA prospective open randomized single center study comparing Sodium lactate (SL) to Hypertonic Saline Solution (HSS) in brain injured adult ICU

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Geneva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hervé Quintard, Professor, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT06110429

Other Study ID Numbers:

701546

First Posted:

Oct 31, 2023

Last Update Posted:

Oct 31, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hervé Quintard, Professor, University Hospital, Geneva

intracerebral hypertension

lactate sodium

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Oct 31, 2023