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

Phase 3

Not yet recruiting

• Conditions: Intra Cerebral Hypertension; Lactate Sodium Solution
• Interventions: Drug: Lactate, Sodium; Drug: Hypertonic saline

• Registration Number: NCT06110429
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-18
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31
• Study Start: 2024-01
• Primary Completion: 2025-06
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lactate sodium	Lactate, Sodium	100 mL of Sodium lactate (Osmolality 2560 mOsm/L) in 15 mins of administration via a central venous catheter
Hypertonic Saline solution	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

Primary Outcome Measures

Name	Time	Method
intracranial pressure (ICP)	240 minutes	Invasive monitoring of intracranial pressure

Secondary Outcome Measures

Name	Time	Method
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