Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage
Use of Levosimendan as Treatment of Aneurysmal SubArachnoid Hemorrhage
Assistance Publique - Hôpitaux de Paris
30 participants
Oct 13, 2023
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
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Interventions
Infusion at 0.1 µg/kg/min at day 1 and day 8
Glucose 5%, solution for injection ECOFLAC at day 1 and day 8
Locations(1)
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NCT05664191