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

• Status: Withdrawn
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Esmolol

Criteria

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