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Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage

NCT04141371 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-03-19

No results posted yet for this study

Summary

Subarachnoid hemorrhage by aneurysmal rupture is a serious condition associated with a high mortality rate. Among the complications presented by these patients, vasospasm is one of the main causes of secondary aggravation, in particular the appearance of delayed neurological deficits following the induced cerebral ischemia. Classically occurring between the 4th and 12th day, with a peak on D7, its prevention is currently often ineffective.

In recent years, many studies have shown that sodium lactate could be an interesting product for neuroprotection. In addition to an anti-osmotic effect that has been demonstrated by our team in the context of post-traumatic intracranial hypertension, a metabolic action has also been observed in periods of metabolic attacks induced by brain attacks. Recently, a vasodilatory action of sodium lactate has been observed from an experimental and clinical point of view.

The purpose of this work is to observe the effect of sodium lactate, compared to placebo, on cerebral hemodynamics measured by perfusion CT (Mean Transit Time MTT) in a population of patients with hemorrhage under the arachnoid.

This work is the preliminary work of a study that will investigate the potential preventive protective effect of sodium lactate on the incidence of vasospasm.

Conditions

  • Subarachnoid Hemorrhage, Aneurysmal

Interventions

DRUG

Molar Sodium Lactate

daily 3-hour infusion of sodium molar lactate during the vasospasm period

DRUG

physiological serum

daily saline infusion over 3 hours during the vasospasm period

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2022-05-05
Completion
2024-06-07

Countries

  • France

Study Locations

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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 NCT04141371 on ClinicalTrials.gov