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

NCT ID: NCT03517670

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2020-08-31

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.

Conditions

Cerebral Vasospasm; Subarachnoid Hemorrhage

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Rhythmic 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

Intervention Type: OTHER

Hematological tolerance

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

Intervention Type: OTHER

Milrinone 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).

Intervention Type: OTHER

Milrinone 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien CADIET, PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

CHU Nantes

Nantes, , France

Countries

France

Other Identifiers

RC17_0451

Identifier Type: -

Identifier Source: org_study_id