NCT04141371

Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage

Effect of Molar Sodium Lactate Filling on Cerebral Hemodynamics in Patients With Severe Meningeal Hemorrhage Multicenter Randomized Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-02-14
• Primary completion: 2022-05-05
• Completion: 2024-06-07
• First posted: 2019-10-28
• Last updated: 2025-03-19

Locations

3 sites across 1 country: France