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Status: Withdrawn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
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