NCT01232400

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
3.7 years until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

November 1, 2010

Last Update Submit

January 7, 2015

Conditions

Subarachnoid Hemorrhage

Keywords

subarachnoid hemorrhageesmololcardiac functioncardiac electrophysiology

Outcome Measures

Primary Outcomes (1)

  • Change in high sensitivity troponin

    Peak to nadir within 7 days

Secondary Outcomes (14)

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

    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 during index hospitalization or first 30 days from index SAH

  • Disability (30 days +/-7).

    30 days from index SAH

  • Change in serum norepinephrine level from peak to nadir

    Baseline versus 4th day after index SAH

  • Change in corrected QT interval

    First week after presentation for index SAH

  • +9 more secondary outcomes

Study Arms (2)

esmolol

EXPERIMENTAL

Esmolol will be used preferentially to control hypertension.

Drug: Esmolol

Standard care

NO INTERVENTION

Standard care for SAH includes other hypertensives such as nicardipine.

Interventions

EsmololDRUG

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.

Also known as: Brevibloc
esmolol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

esmolol

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • William J Meurer, MD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2016

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

US(1)