Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage
Status:
Not yet recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
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