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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

Sub-arachnoid Haemorrhage

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

Inclusion Criteria3

  • 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 Criteria10

  • 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

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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