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

NCT06110429 | Unknown Phase 3 DMC

• 1 other identifier: 701546
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intra Cerebral Hypertension; Lactate Sodium Solution

Keywords

intracerebral hypertension; lactate sodium

Outcome Measures

Primary Outcomes (1)

• intracranial pressure (ICP)

  Invasive monitoring of intracranial pressure

  240 minutes

Secondary Outcomes (4)

• Percentage of successfully treated episodes

  48 hours

• Oxygen tissular pressure

  240 minutes

• Neurological status at discharge of ICU

  through study completion, an average of 30 days

• Number of episodes of intracranial hypertension

  through study completion, an average of 30 days

Study Arms (2)

lactate sodium

EXPERIMENTAL

100 mL of Sodium lactate (Osmolality 2560 mOsm/L) in 15 mins of administration via a central venous catheter

Drug: Lactate, Sodium

Hypertonic Saline solution

ACTIVE COMPARATOR

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

Interventions

Lactate, Sodium DRUG

Isovolemic and osmotic infusion Comparison of osmotic agent

lactate sodium

Hypertonic saline DRUG

Isovolemic and osmotic infusion Comparison of osmotic agent

Hypertonic Saline solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant woman
• Bilateral fixed dilatated pupils
• Initial hypernatremia (\>155 mmol/l)
• Penetrating head injury
• Active participation to another trial (Clin B, C)

Sponsors & Collaborators

• University Hospital, Geneva: lead

MeSH Terms

Interventions

Sodium Lactate; Saline Solution, Hypertonic

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals; Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Herve Quintard, MD, PhD

CONTACT

+41795532188; herve.quintard@hcuge.ch

aurélie Perret

CONTACT

+41795530805; aurelie.perret@hcuge.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: October 31, 2023
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share