Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia
Efficacy of 10 Days Intravenous Milrinone Treatment to Optimize Cerebral Hemodynamic and Prevent Delayed Cerebral Ischemia (DCI) in Patients with Severe Subarachnoid Hemorrhage Due to Intracranial Aneurysm Rupture
University Hospital, Toulouse
234 participants
Jul 25, 2021
INTERVENTIONAL
Conditions
Summary
The present study is a randomized, multi-center, double-blind, prospective study that tests the efficacy of intravenous milrinone to optimize cerebral hemodynamic and prevent delayed cerebral ischemia (DCI) during the high-risk period (day 4- day 14) in patients with severe subarachnoid hemorrhage due to intracranial aneurysm rupture (SAHa) (WFNS IV-V). The main objective is to evaluate, in comatose patients and / or sedated on D3 following a severe SAHa (WFNS IV -V), the effect of 10 days of milrinone versus placebo, in addition to the usual management, on the volume of DCI lesions measured on CT scan at 1 month.
Eligibility
Inclusion Criteria6
- patients with severe SAHa (WFNS IV and V,) whose neurological examination is impossible because of coma (Glasgow coma score of 8 or less) or need for sedation at D3
- absence of pre-existing neurological handicap (mRS 0-2)
- major patient (≥ 18 years)
- affiliation to social security or benefiting through a third person
- free patient, without tutorship or curatorship or under judicial protection
- obtaining a signed informed consent by a relative (or the person of trust) after clear and fair information about the study.
Exclusion Criteria15
- patients with non-severe SAHa (WFNS I, II and III)
- Occurrence of a major complication (haemorrhagic or ischaemic) documented during the procedure of securing the aneurysm and endangering the short-term vital prognosis
- heart failure requiring inotropic administration at the time of randomization
- ICHT at the time of randomisation (ICP> 25 mmHg for at least 20 min)
- known severe obstructive heart diseases
- flutter patient or atrial fibrillation
- hypotension and / or severe hypovolemia with hemodynamic instability
- septic shock
- acute / chronic renal insufficiency (Cl <50ml / min)
- major hydroelectrolytic disorders (hypokalemia <3 mmol / L)
- known hypersensitivity to milrinone or any of the excipients
- early limitation of life-sustaining care
- pregnancy, breastfeeding
- permanent contraindications to MRI
- participation in another clinical interventional study
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Interventions
administration of milrinone (0.75 μg / kg / min, intravenous) from Day 4 to Day 14
administration of placebo (intravenous glucose 5%) from Day 4 to Day 14
Locations(5)
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NCT04282629