Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: Simendan

Criteria

Inclusion Criteria:

• All adult patients (18 to 75 years old),

• hospitalized in surgical intensive care at Lariboisière Hospital for subarachnoid haemorrhage of aneurysmal origin

• WFNS clinical score of I to IV and a mFisher score of 3 or 4.

Exclusion Criteria:

• pregnant women

• contraindications to levosimendan (including hypersensitivity to levosimendan, severe hypotension (mean arterial pressure less than 65 mmHg), tachycardia (heart rate greater than 120 bpm), cardiac mechanical obstructions)

• severe renal failure (creatinine clearance < 30 ml/min)

• severe hepatic failure (signs of hepatic encephalopathy) or chronic liver disease

• history of torsades de pointes

• pre-existing severe neurovascular pathologies.

• Moribund patients.

• Patient not affiliated to social security

• Patient participating in another interventional research

• Patients under legal guardianship or curatorship