None listed
Conditions
Brief summary
Background: Cerebral vasospasm is a relatively common complication following aneurysmal subarachnoid haemorrhage (aSAH), which is associated with significant morbidity and mortality. Current treatment options to treat cerebral vasospasm are limited. Intravenous milrinone infusion is a potentially promising treatment with a relatively low incidence of adverse effects however, has not been explored in a randomized controlled trial. Aim: This will be a pilot study to determine the safety and feasibility of intravenous milrinone infusion as a treatment for cerebral vasospasm following aSAH compared to current standard therapy. Hypothesis: Intravenous milrinone will be a feasible treatment option in the management of cerebral vasospasm following aSAH Methods: The proposed study is a pilot study trialling intravenous milrinone infusion in patients with radiographically confirmed cerebral vasospasm following aSAH. 20 patients will be allocated to receive IV milrinone alongside standard therapy. A control group of 20 patients will receive standard therapy alone. The primary outcome measured will include the dose and duration of milrinone infusion. Secondary outcomes will include the incidence of adverse events, the resolution of cerebral vasospasm on CT or digital-subtraction angiography (DSA) and the vasopressor requirement.
Interventions
The intervention will be continuous intravenous milrinone infusion, for up to 7 days. To commence at time of radiological diagnosis of vasospasm at an initial dose of 0.25mcg/kg/min. Titrated to a maximum of 0.75mcg/kg/min as tolerated. This will be in addition to standard care which will consist of induced hypertension, with fluid therapy and noradrenaline infusion as directed by the treating clinician. Oral nimodipine at a dose of 60mg every 4hours will also be prescribed as part of standard t
The intervention will be continuous intravenous milrinone infusion, for up to 7 days. To commence at time of radiological diagnosis of vasospasm at an initial dose of 0.25mcg/kg/min. Titrated to a maximum of 0.75mcg/kg/min as tolerated. This will be in addition to standard care which will consist of induced hypertension, with fluid therapy and noradrenaline infusion as directed by the treating clinician. Oral nimodipine at a dose of 60mg every 4hours will also be prescribed as part of standard therapy.
Sponsors
Monash Medical Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults Admitted to ICU Radiologically confirmed vasospam
Exclusion criteria
Whole territory cerebral infarction in the vasospasm territory on CT scan Cardiac failure requiring inotropic support Pregnancy Any contraindication to milrinone
Outcome results
None listed