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

NCT ID: NCT01232400

Last Updated: 2015-01-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-08-31

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

esmolol

Esmolol will be used preferentially to control hypertension.

Group Type: EXPERIMENTAL

Esmolol

Intervention Type: DRUG

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.

Standard care

Standard care for SAH includes other hypertensives such as nicardipine.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Brevibloc

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

William J Meurer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William J Meurer, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Health System

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM31297

Identifier Type: -

Identifier Source: org_study_id