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

NCT ID: NCT06110429

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2026-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

lactate sodium

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

Group Type: EXPERIMENTAL

Lactate, Sodium

Intervention Type: DRUG

Isovolemic and osmotic infusion Comparison of osmotic agent

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

Group Type: ACTIVE_COMPARATOR

Hypertonic saline

Intervention Type: DRUG

Isovolemic and osmotic infusion Comparison of osmotic agent

Interventions

Lactate, Sodium

Isovolemic and osmotic infusion Comparison of osmotic agent

Intervention Type: DRUG

Hypertonic saline

Isovolemic and osmotic infusion Comparison of osmotic agent

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Hervé Quintard

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Herve Quintard, MD, PhD

Role: CONTACT

Phone: +41795532188

Email: herve.quintard@hcuge.ch

aurélie Perret

Role: CONTACT

Phone: +41795530805

Email: aurelie.perret@hcuge.ch

Other Identifiers

701546

Identifier Type: -

Identifier Source: org_study_id