Cerebral Vasospasm, Subarachnoid Hemorrhage
Conditions
Keywords
Cerebral vasospasm, Subarachnoid hemorrhage, Milrinone, Hemodynamic tolerance
Brief summary
The aim of this study is to evaluate the tolerance of intravenous milrinone combined to the current standard treatment for cerebral vasospasm following subarachnoid hemorrhage. Assessment of IV milrinone safety in this setting is mandatory before the conduction of a large study assessing its effectiveness.
Detailed description
The aim of this prospective observational study is to evaluate the hemodynamic tolerance of intravenous milrinone for the treatment of arterial vasospasm following subarachnoid hemorrhage. Intravenous milrinone is part of our standard care protocol for the management of cerebral vasospasm in association with nimodipine (intravenous or enteral route) and high arterial blood pressure (mean arterial pressure of 100-120 mmHg, spontaneously or induced by volume expansion and norepinephrine). All patients of our ICU who were diagnosed with cerebral arterial vasospasm during the few days following a subarachnoid hemorrhage will be included.
Interventions
OTHERRhythmic tolerance
Rhythmic intolerance is defined by the occurrence of arrhythmia prompting the initiation of an antiarrhythmic medication and the need to decrease or even to stop the infusion of milrinone
OTHERHematological tolerance
Hematological tolerance will be considered good if milrinone infusion was not interrupted owing to the occurrence of thrombocytopenia
OTHERMilrinone efficiency on cerebral vasospasm
It will be assessed using ultrasound measurements of middle cerebral arteries velocities. A decrease of at least 20% of the mean velocity or of the Lindegaard index will be considered as a significant positive effect of the treatment (including milrinone).
OTHERMilrinone efficiency using the modified Rankin scale
Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to perform all usual activities, despite certain symptoms, 2= Slight disability. Able to take care of his own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderate severe disability. Unable to meet their own physical needs without help and unable to walk without help, 5 Severe disability. Needs constant care and attention, bedridden, incontinent, 6 = Death.
Sponsors
Nantes University Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects 18 years * Hospitalized in our intensive care unit * Subarachnoid hemorrhage proven on CT angiogram * Cerebral vasospasm proven on CT angiogram
Exclusion criteria
* Pregnant women * Minor * Major under guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic tolerance during treatment: defined by a stable mean blood pressure of 100-120 | At 6 months. | A good hemodynamic tolerance is defined by a stable mean blood pressure of 100-120 mmHg without neither the need to decrease milrinone infusion rate below 0.5 g.kg-1.min-1 nor the need to increase norepinephrine above 1g.kg-1.min-1 Safety Issue: No |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rhythmic tolerance: defined by the occurrence of arrhythmia prompting the initiation of | Rhythmic tolerance will be assessed for the duration of treatment, which will be on average one month.Heart rate and rhythm will be measured continuously, but assessed for fluctuation outside the reference range daily (during the length of treatment). | Rhythmic intolerance is defined by the occurrence of arrhythmia prompting the initiation of an antiarrhythmic medication and the need to decrease or even to stop the infusion of milrinone Safety Issue: No |
| Hematological tolerance: will be considered good if milrinone infusion was not interrupted | Hematological tolerance will be assessed daily through measuring platelet count for the duration of treatment. | Hematological tolerance will be considered good if milrinone infusion was not interrupted owing to the occurrence of thrombocytopenia Safety Issue: No |
| Milrinone efficiency on cerebral vasospasm | Milrinone efficiency on cerebral vasospasm will be assessed for the duration of treatment, which will be on average one month. Mean velocity and the lindegard index will be initially measured at 0, 2, 12 and 24 hours; and subsequently daily. | It will be assessed using ultrasound measurements of middle cerebral arteries velocities. A decrease of at least 20% of the mean velocity or of the Lindegaard index will be considered as a significant positive effect of the treatment (including milrinone). Safety Issue: No |
| Milrinone efficiency on patient-centered neurological outcome using the modified Rankin scale | At 6 months. | Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to perform all usual activities, despite certain symptoms, 2= Slight disability. Able to take care of his own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderate severe disability. Unable to meet their own physical needs without help and unable to walk without help, 5 Severe disability. Needs constant care and attention, bedridden, incontinent, 6 = Death. Safety Issue: No |
Countries
France
Outcome results
None listed