Clinical trial NCT01343329: Controlling Hyperadrenergic Activity in Neurologic Injury
Official title: Controlling Hyperadrenergic Activity in Neurologic Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Traumatic Brain Injury
Dysautonomia
Keywords: Traumatic Brain Injury
Dysautonomia
Brain Injury
Sympathetic hyperactivity
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Controlling heart rate in traumatic brain injured patients
timeFrame: 72 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Wendy Ziai, MD
role: PRINCIPAL_INVESTIGATOR
References:
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