Study to Evaluate Esmolol (Brevibloc) to Manage Cardiac Function in Patients With Subarachnoid Hemorrhage



Status:Not yet recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:July 2014
End Date:August 2016
Contact:William J Meurer, MD, MS
Email:wmeurer@umich.edu
Phone:734-615-2766

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Adrenergic Blockade After Subarachnoid Hemorrhage

The purpose of this study is to evaluate the clinical effect of esmolol treatment on cardiac
function and electrophysiology; to assess the effects of esmolol treatment on serum
adrenergic and cardiac biomarkers; to explore the safety of esmolol treatment shortly after
subarachnoid hemorrhage (SAH). Patients will be followed for a maximum of 1 month after the
index SAH. The primary outcome will be change in systolic function - ejection fraction by
Simpson's rule (baseline versus Day 7 +/- 2 after SAH).

Subarachnoid hemorrhage (SAH) remains one of the most devastating forms of stroke. Over 25%
of all stroke related potential years of life lost are from SAH. Outcomes are adversely
affected by secondary ischemia from cerebral vasospasm, along with cardiac complications.
Trials performed in patients with SAH have demonstrated benefit after the administration of
beta blockers - reducing mortality nearly in half; but concerns over diminishing cerebral
perfusion inhibited the widespread adoption of this therapy. Our specific aims are as
follows: 1. To evaluate the clinical effect of esmolol treatment on cardiac systolic and
diastolic function, along with cardiac electrophysiology; 2. To assess the effects of
esmolol treatment on serum adrenergic and cardiac biomarkers; 3. To explore the safety of
esmolol shortly after SAH. The primary outcome will be change in systolic function -
ejection fraction by Simpson's rule (baseline versus Day 7 +/- 2 after SAH).

Inclusion Criteria:

- Subarachnoid hemorrhage presumed to be the result of ruptured aneurysm

- Age 18 years old or greater

- Able to enroll within 24 hours of onset of symptoms

- Systolic blood pressure over 140 mm Hg OR administration of antihypertensives after
presentation

Exclusion Criteria:

- Withdrawal of life support imminent (within six hours)

- Known heart failure or cardiomyopathy AND ejection fraction 35% or below

- Prisoner or pregnant female

- Ongoing vasopressor administration to maintain SBP, or clinical suspicion of left
ventricular failure

- Clinically important arrhythmias (history of cardiac arrest or ventricular
arrhythmias), conduction abnormalities (Mobitz Type 2, 3rd degree AV block, or
symptomatic Mobitz 1 without pacemaker), clinical cardiogenic shock, or overt
clinical heart failure

- Active bronchospastic disease (ongoing bronchospasm after SAH presentation or current
treatment with oral corticosteroids for asthma or obstructive lung disease)

- End stage renal disease
We found this trial at
1
site
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
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Ann Arbor, MI
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