Safety of Intravenous Milrinone for the Treatment of Subarachnoid Hemorrhage-induced Vasospasm

Nantes University Hospital60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cerebral Vasospasm Subarachnoid Hemorrhage

Interventions

Rhythmic toleranceOTHER

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

Hematological toleranceOTHER

Hematological tolerance will be considered good if milrinone infusion was not interrupted owing to the occurrence of thrombocytopenia

Milrinone efficiency on cerebral vasospasmOTHER

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Nantes

Nantes, France

Outcomes

Primary Outcomes

Hemodynamic tolerance during treatment: defined by a stable mean blood pressure of 100-120

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

Time frame: At 6 months.

Secondary Outcomes

Rhythmic tolerance: defined by the occurrence of arrhythmia prompting the initiation of

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

Time frame: 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).

Hematological tolerance: will be considered good if milrinone infusion was not interrupted

Hematological tolerance will be considered good if milrinone infusion was not interrupted owing to the occurrence of thrombocytopenia Safety Issue: No

Time frame: Hematological tolerance will be assessed daily through measuring platelet count for the duration of treatment.

Milrinone efficiency on cerebral vasospasm

Time frame: 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.

Data from ClinicalTrials.gov

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