Subarachnoid HemorrhageABASHNCT01232400
Study to Evaluate Esmolol (Brevibloc) to Manage Cardiac Function in Patients With Subarachnoid Hemorrhage
A study testing Esmolol in people with Subarachnoid Hemorrhage, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: 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).
Read the 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).
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Esmolol
- Keywords
- subarachnoid hemorrhage, esmolol, cardiac function, cardiac electrophysiology
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
Also called Brevibloc
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:
- Heart rate less than 70 bpm.
- Systolic blood pressure less than 120 mmHg
- Maximum dose of esmolol of 200 mcg/kg/minute is reached.
| Study group | Role | What they receive |
|---|---|---|
| esmolol | Experimental | Esmolol will be used preferentially to control hypertension. Receives: Drug: Esmolol |
| Standard care | No intervention | Standard care for SAH includes other hypertensives such as nicardipine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in high sensitivity troponin
Measured: Peak to nadir within 7 days
Secondary outcomes (14)
Mean difference in time weighted average amount of cerebral perfusion pressure below 60 mmHg.
Measured: Measured for 4 days from index SAH
Proportion experiencing serious adverse event: hypotension requiring vasopressor (excluding during anesthesia), neurological deterioration, serious bronchospasm, and in hospital case fatality.
Measured: Measured during index hospitalization or first 30 days from index SAH
Disability (30 days +/-7).
Measured: 30 days from index SAH
Change in serum norepinephrine level from peak to nadir
Measured: Baseline versus 4th day after index SAH
Change in corrected QT interval
Measured: First week after presentation for index SAH
Proportion with echocardiographic wall motion abnormalities at baseline and day 7 +- 2
Measured: First week after presentation.
Proportion with electrocardiographic abnormalities cumulative through day 7
Measured: Baseline, and at first week after presentation.
Proportion with depressed ejection fraction on initial echocardiogram 36 - 49%
Measured: Baseline (within 24 hours of presentation for index SAH)
Proportion with life-threatening arrhythmias or cardiac arrest
Measured: Measured through end of index hospitalization (approximately 30 days maximum)
Change in serum troponin and BNP levels from peak to nadir
Measured: baseline through end of hospitalization
Proportion with abnormal 30-day echocardiogram
Measured: 30 days post index SAH
Proportion with symptomatic cerebral vasospasm
Measured: baseline until end of hospitalization
Proportion with radiographic cerebral vasospasm
Measured: baseline until end of hospitalization
Change in systolic function - ejection fraction by Simpson's rule (baseline vs Day 7 +/- 2)
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: Funding withdrawn. Design not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William J Meurer, University of Michigan
- Investigators
- William J Meurer, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232400
- Sponsor's protocol ID
- HUM31297
- Acronym
- ABASH
- Status last verified
- Jan 2015
- First submitted
- 1 Nov 2010
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenergic Blockade After Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01232400
- Acronym / sponsor ID
- ABASH / HUM31297
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- subarachnoid hemorrhage, esmolol, cardiac function, cardiac electrophysiology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn. Design not feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esmolol | Experimental | Drug: EsmololEsmolol will be used preferentially to control hypertension. |
| Standard care | No intervention | –Standard care for SAH includes other hypertensives such as nicardipine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsmololAlso: BreviblocThe 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. | Drug | esmolol |
Primary outcome
Change in high sensitivity troponin
Time frame: Peak to nadir within 7 days
14 secondary outcomes
Mean difference in time weighted average amount of cerebral perfusion pressure below 60 mmHg.
Time frame: Measured for 4 days from index SAH
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
Disability (30 days +/-7).
Time frame: 30 days from index SAH
Change in serum norepinephrine level from peak to nadir
Time frame: Baseline versus 4th day after index SAH
Change in corrected QT interval
Time frame: First week after presentation for index SAH
Proportion with echocardiographic wall motion abnormalities at baseline and day 7 +- 2
Time frame: First week after presentation.
Proportion with electrocardiographic abnormalities cumulative through day 7
Time frame: Baseline, and at first week after presentation.
Proportion with depressed ejection fraction on initial echocardiogram 36 - 49%
Time frame: Baseline (within 24 hours of presentation for index SAH)
Proportion with life-threatening arrhythmias or cardiac arrest
Time frame: Measured through end of index hospitalization (approximately 30 days maximum)
Change in serum troponin and BNP levels from peak to nadir
Time frame: baseline through end of hospitalization
Proportion with abnormal 30-day echocardiogram
Time frame: 30 days post index SAH
Proportion with symptomatic cerebral vasospasm
Time frame: baseline until end of hospitalization
Proportion with radiographic cerebral vasospasm
Time frame: baseline until end of hospitalization
Change in systolic function - ejection fraction by Simpson's rule (baseline vs Day 7 +/- 2)
Time frame: 5-7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J Meurer, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esmolol in people with Subarachnoid Hemorrhage, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in high sensitivity troponin (time frame: Peak to nadir within 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2015; AzTrials last refreshed its copy on 31 Oct 2026.