Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia (OPTIMIL)
Aneurysmal Subarachnoid Hemorrhage
About this trial
This is an interventional treatment trial for Aneurysmal Subarachnoid Hemorrhage focused on measuring Milrinone, Vasospasm, Delayed Cerebral Ischemia
Eligibility Criteria
Inclusion Criteria:
- patients with severe SAHa (WFNS IV and V,) whose neurological examination is impossible because of coma 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 Criteria:
- patients with non-severe SAHa (WFNS I, II and III)
- Occurrence of a documented ischemic complication during the procedure of aneurysm treatment: transient or permanent arterial occlusion, visualization of a thrombus, and dissection of an axis requiring stenting.
- 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
- pregnancy, breastfeeding
- permanent contraindications to MRI
- participation in another clinical study
Sites / Locations
- University Hospital Bordeaux
- CHUGA
- University Hospital of La RéunionRecruiting
- HCLRecruiting
- University Hospital of ToulouseRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Milrinone
Standard Care
"milrinone" group benefiting from an identical treatment to the standard care group and in addition, administration of milrinone (0.75 μg / kg / min, intravenous) from Day 4 to Day 14. In case of suspicion of vasospasm and after ineffective effect of medical measures (euvolemia and increase in mean arterial pressure), an endovascular treatment will be possible. The occurrence of vasospasm will be monitored closely with clinical examination and cerebral tissue oxygen pressure (PtiO2). From D4 to D14, general and biological data, clinical examination will be collected daily. Intensive care unit complications (neurologic, pulmonary, cardiac and septic complications) will be collected. At 1 month, the volume of DCI lesions will be measured on CT scan. Neurologic prognosis, quality of life and mortality will be studied at 1 month, 3 month, 6 month and 1 year. Adverse events will be monitored closely.
The standard care group will follow the recommended management of SAHa and will receive a placebo (intravenous glucose 5%) from Day 4 to Day 14. In case of suspicion of vasospasm and after ineffective effect of medical measures (euvolemia and increase in mean arterial pressure), an endovascular treatment will be possible. The occurrence of vasospasm will be monitored closely with clinical examination and cerebral tissue oxygen pressure (PtiO2). From D4 to D14, general and biological data, clinical examination will be collected daily. Intensive care unit complications (neurologic, pulmonary, cardiac and septic complications) will be collected. At 1 month, the volume of DCI lesions will be measured on CT scan. Neurologic prognosis, quality of life and mortality will be studied at 1 month, 3 month, 6 month and 1 year. Adverse events will be monitored closely.