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Effect of Molar Sodium Lactate Filling on Cerebral Hemodynamics in Patients With Severe Meningeal Hemorrhage Multicenter Randomized Study
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Grenoble Hospital
Grenoble, France
Marseille Hospital
Marseille, France
Carole ICHAI
Nice, France
Start Date
February 14, 2022
Primary Completion Date
May 5, 2022
Completion Date
June 7, 2024
Last Updated
March 19, 2025
3
ACTUAL participants
Molar Sodium Lactate
DRUG
physiological serum
DRUG
Lead Sponsor
Centre Hospitalier Universitaire de Nice
NCT06119061
NCT06766422
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05103566