RecruitingPhase 2NCT05664191

Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage

Use of Levosimendan as Treatment of Aneurysmal SubArachnoid Hemorrhage


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

30 participants

Start Date

Oct 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Sub-arachnoid haemorrhage (SAH) are often due to ruptured intracerebral aneurysms and are associated with an importante morbi-mortality. SAH are often complicated by delayed cerebral ischemia (DCI) potentially due to cerebral vasospasm (CVS). A recent study showed that levosimendan, an inotropic and vasodilatory drug, could reduce the incidence of CVS and potentially improve patient outcome. In this pilot randomized controlled trial, we will evaluate the impact Levosimendan vs Placebo in SAH patient on the occurrence of CVS and DCI. Study population: adult patient admitted to ICU for aneurysmal SAH WFNS grade I-IV and mFisher 3-4. Intervention: Levosimendan (0.1 µg/kg/min) or placebo infusion at Day 1 and 8. Primary outcome: incidence of DCI or CVS at day 14 Duration of the study: 24 months Number of patients: 30 (15 patients per group) Number of center: 1


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Levosimendan and Placebo for people with sub-arachnoid haemorrhage. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLevosimendan

Infusion at 0.1 µg/kg/min at day 1 and day 8

OTHERPlacebo

Glucose 5%, solution for injection ECOFLAC at day 1 and day 8


Locations(1)

Hôpital Lariboisière, Service d'anesthésie Réanimation

Paris, France, France

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NCT05664191