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

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ClinicalTrials.gov Identifier: NCT01232400
Recruitment Status : Withdrawn (Funding withdrawn. Design not feasible.)
First Posted : November 2, 2010
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
William J Meurer, University of Michigan

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Drug: Esmolol Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adrenergic Blockade After Subarachnoid Hemorrhage
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: esmolol
Esmolol will be used preferentially to control hypertension.
 Drug: Esmolol

The initial esmolol infusion will be 50 mcg/kg/minute IV. This will be increased by 25 mcg/kg/minute every 15 minutes until one of the following situations is reached:

  1. Heart rate less than 70 bpm.
  2. Systolic blood pressure less than 120 mmHg
  3. Maximum dose of esmolol of 200 mcg/kg/minute is reached.
Other Name: Brevibloc
No Intervention: Standard care
Standard care for SAH includes other hypertensives such as nicardipine.


Outcome Measures
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Primary Outcome Measures :
  1. Change in high sensitivity troponin [ Time Frame: Peak to nadir within 7 days ]

Secondary Outcome Measures :
  1. Mean difference in time weighted average amount of cerebral perfusion pressure below 60 mmHg. [ Time Frame: Measured for 4 days from index SAH ]
  2. Proportion experiencing serious adverse event: hypotension requiring vasopressor (excluding during anesthesia), neurological deterioration, serious bronchospasm, and in hospital case fatality. [ Time Frame: Measured during index hospitalization or first 30 days from index SAH ]
  3. Disability (30 days +/-7). [ Time Frame: 30 days from index SAH ]
  4. Change in serum norepinephrine level from peak to nadir [ Time Frame: Baseline versus 4th day after index SAH ]
  5. Change in corrected QT interval [ Time Frame: First week after presentation for index SAH ]
  6. Proportion with echocardiographic wall motion abnormalities at baseline and day 7 +- 2 [ Time Frame: First week after presentation. ]
  7. Proportion with electrocardiographic abnormalities cumulative through day 7 [ Time Frame: Baseline, and at first week after presentation. ]
  8. Proportion with depressed ejection fraction on initial echocardiogram 36 - 49% [ Time Frame: Baseline (within 24 hours of presentation for index SAH) ]
  9. Proportion with life-threatening arrhythmias or cardiac arrest [ Time Frame: Measured through end of index hospitalization (approximately 30 days maximum) ]
  10. Change in serum troponin and BNP levels from peak to nadir [ Time Frame: baseline through end of hospitalization ]
  11. Proportion with abnormal 30-day echocardiogram [ Time Frame: 30 days post index SAH ]
  12. Proportion with symptomatic cerebral vasospasm [ Time Frame: baseline until end of hospitalization ]
  13. Proportion with radiographic cerebral vasospasm [ Time Frame: baseline until end of hospitalization ]
  14. Change in systolic function - ejection fraction by Simpson's rule (baseline vs Day 7 +/- 2) [ Time Frame: 5-7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232400


Locations
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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: William J Meurer, MD, MS University of Michigan
More Information
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Responsible Party: William J Meurer, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01232400    
Other Study ID Numbers: HUM31297
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015
Keywords provided by William J Meurer, University of Michigan:
subarachnoid hemorrhage
esmolol
cardiac function
cardiac electrophysiology
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Esmolol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs