Clinical trial NCT03517670: Safety of Intravenous Milrinone for the Treatment of Subarachnoid Hemorrhage-induced Vasospasm
Official title: Safety of Intravenous Milrinone for the Treatment of Subarachnoid Hemorrhage-induced Vasospasm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Vasospasm
Subarachnoid Hemorrhage
Keywords: Cerebral vasospasm
Subarachnoid hemorrhage
Milrinone
Hemodynamic tolerance
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Purpose: Treatment Study Phase: NA Intervention Model: Single group Number of Arms: 1 Masking: Open label Allocation: NA Study Endpoint Classification: Safety Enrollment: 60 participants

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemodynamic tolerance during treatment: defined by a stable mean blood pressure of 100-120
timeFrame: At 6 months.
Secondary outcomes:
measure: Rhythmic tolerance: defined by the occurrence of arrhythmia prompting the initiation of
timeFrame: 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).
measure: Hematological tolerance: will be considered good if milrinone infusion was not interrupted
timeFrame: Hematological tolerance will be assessed daily through measuring platelet count for the duration of treatment.
measure: Milrinone efficiency on cerebral vasospasm
timeFrame: 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.
measure: Milrinone efficiency on patient-centered neurological outcome using the modified Rankin scale
timeFrame: At 6 months.
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: Nantes University Hospital
name: Julien CADIET, PH
role: PRINCIPAL_INVESTIGATOR
References: