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

NCT06110429 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-10-31

No results posted yet for this study

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

Interventions

DRUG

Lactate, Sodium

Isovolemic and osmotic infusion Comparison of osmotic agent

DRUG

Hypertonic saline

Isovolemic and osmotic infusion Comparison of osmotic agent

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-06-30
Completion
2026-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06110429 on ClinicalTrials.gov