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

Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Subarachnoid Hemorrhage

Intervention: Esmolol (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: University of Michigan

Official(s) and/or principal investigator(s):
William J Meurer, MD, MS, Principal Investigator, Affiliation: University of Michigan

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).

Clinical Details

Official title: Adrenergic Blockade After Subarachnoid Hemorrhage

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in high sensitivity troponin

Secondary outcome:

Mean difference in time weighted average amount of cerebral perfusion pressure below 60 mmHg.

Proportion experiencing serious adverse event: hypotension requiring vasopressor (excluding during anesthesia), neurological deterioration, serious bronchospasm, and in hospital case fatality.

Disability (30 days +/-7).

Change in serum norepinephrine level from peak to nadir

Change in corrected QT interval

Proportion with echocardiographic wall motion abnormalities at baseline and day 7 +- 2

Proportion with electrocardiographic abnormalities cumulative through day 7

Proportion with depressed ejection fraction on initial echocardiogram 36 - 49%

Proportion with life-threatening arrhythmias or cardiac arrest

Change in serum troponin and BNP levels from peak to nadir

Proportion with abnormal 30-day echocardiogram

Proportion with symptomatic cerebral vasospasm

Proportion with radiographic cerebral vasospasm

Change in systolic function - ejection fraction by Simpson's rule (baseline vs Day 7 +/- 2)

Detailed description: 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).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of Michigan Health System, Ann Arbor, Michigan 48109, United States
Additional Information

Starting date: July 2014
Last updated: January 7, 2015

Page last updated: August 23, 2015

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