subarachnoid hemorrhages of aneurysmal origin (HSAa)
Conditions
Interventions
Trade Name: ZIMINO 2,5 mg/ml (Levosimendan)
Product Name: ZIMINO 12,5 mg
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of
Sponsors
APHP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - All adult patients (? 18 to 75), - hospitalized in surgical intensive care at Lariboisière for subarachnoid hemorrhage of aneurysm origin - (HSAa) clinical score WFNS I to IV and Fisher score 3 or 4. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: pregnant women - contraindications to levosimendan (including hypersensitivity to levosimendan, severe hypotension, tachycardia, cardiac mechanical obstructions) - severe renal impairment (creatinine clearance <30 ml / min) - severe hepatic insufficiency (signs of hepatic encephalopathy); - history of torsades de pointes - severe pre-existing neuro-vascular pathologies. - Moribund patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of levosimendan in patients admitted to intensive care for HSAa at high risk of ASV (WFNS Grade I to IV and Fisher score 3 or 4) on the occurrence of ASV.;Secondary Objective: 1.evaluate the effects of treatment with Levosimendan on: mortality on D14, D28 and D90; the occurrence of ICD within 14 days of the bleeding. 2.Assess the effects of levosimendan treatment on mRS at 3 months 3.assessment of the effects of levosimendan treatment on cardiac dysfunction 4.evaluation of the effects of levosimendan treatment on cerebral perfusion 5.assessment of the effects of treatment with levosimendan on the length of stay in intensive care;Primary end point(s): the occurrence of cerebral arterial vasospasm within 14 days of the bleeding;Timepoint(s) of evaluation of this end point: June 2024 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.the cumulative incidence of death rate, ICDs and vasospasms 2. The mRS score at 3 months 3. The impact of Levosimendan treatment on cardiac dysfunction will be assessed by: - Peak value of serum catecholamines (noradrenaline, adrenaline) within 5 days of admission - Number of days alive on D14 without catecholamines and maximum dose (noradrenaline, dobutamine, dopamine, adrenaline, isoprenaline) if used. - The time to onset of the troponin and BNP peak and their values - Systolic and diastolic heart function assessed by echocardiography 4. The effect of treatment with Levosimendan on cerebral perfusion will be assessed by: - Daily clinical course with Glasgow score reading - Evolution of transcranial Doppler performed on a daily basis - Occurrence and extent of secondary cerebral ischemia diagnosed by systematic MRI at 3 months.;Timepoint(s) of evaluation of this end point: June 2021 | — |
Countries
France
Contacts
Public ContactDRCI; Hopital Saint-Louis
APHP
Outcome results
None listed