Controlling Hyperadrenergic Activity in Neurologic Injury

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Traumatic Brain Injury, Dysautonomia

In brief

Traumatic brain injury (TBI) is frequently associated with a hyperadrenergic state accompanied by elevated levels of plasma catecholamines. In its more severe presentation, the hyperadrenergic state presents as dysautonomia, which is characterized by paroxysmal alteration in vital signs, including tachycardia. The investigators hypothesize that intravenous (IV) esmolol is as effective at controlling heart rate in hyperadrenergic states as oral propranolol, which is the standard of care. Our primary endpoint is efficacy of IV esmolol vs a PRN regimen of intermittent B-blockade in controlling heart rate below a pre-specified level (\< 100 bpm) after Traumatic Brain Injury (TBI) or hemorrhagic neurologic injury. Heart rates will be recorded continuously as well as hourly.

Key facts

Study ID

NCT01343329

Run by

Johns Hopkins University

People needed

0

Starts

2011-07-01

Expected to finish

2014-02-14

Last updated by the study team

2017-04-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• TBI (Moderate/Severe TBI (GCS 12 or Head AIS>1) or hemorrhagic neurologic injury
• Hyperadrenergic Activity: At least one paroxysmal episode (lasting at least 15 minutes) of Heart Rate 110 beats per minute during two or more consecutive days plus at least two more of the following that may not be better explained by another disease process (ex: sepsis):
• Temperature of 38.5C Respiratory Rate 20 breaths per minute Agitation Diaphoresis Dystonia Stimulus responsive ("triggering of paroxysm")
• Informed Consent obtained

You may not qualify if…

• Patients that do not meet criteria for dysautonomia (as stated above)
• Age <18 years
• Pregnancy
• Hypotension - requiring pressor therapy to maintain baseline adequate CPP or mean arterial pressure
• Cardiac arrhythmia - sinus bradycardia (HR <60), 2nd or 3rd degree AV block
• Hemodynamic contraindications to intravenous beta-blockade such as a documented history of congestive heart failure (CHF), dependency on cardiac inotropes or documented bronchospastic disease
• Any patient on chronic beta blockade as an outpatient.
• Life expectancy < 48 hours or patients with "do not resuscitate orders"
• Ongoing seizure activity
• Informed consent not obtained

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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