Clinical trial NCT02957331: Beta Blockade in in Traumatic Brain Injury
Official title: Beta-Adrenergic Blockade for Suppression of Catecholamine Surge Following Traumatic Brain Injury: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Injuries, Traumatic
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is test the effect of beta-adrenergic blockade on mortality in patients with traumatic brain injury with the hypothesis being that the addition of beta blockade to the treatment regime of this patient population will lower mortality and supress the catecholamine surge that accompanies traumatic brain injury as compared to those who do not receive beta blockade.

Half the patients will be randomized to receive propranolol and half will be randomized to receive no beta blocker.

Detailed description: The use of Beta-adrenergic blockade is not currently the standard of care of patients with traumatic brain injury. Traumatic brain injury is a common problem in our society with greater than 1.5 million cases occurring annually and over 50,000 deaths per year in the civilian population in the United States. Medical therapy has long consisted of monitoring intracranial pressure and supportive measures designed to limit intracranial pressure. Two retrospective observational studies completed at the University of Tennessee demonstrate that the addition of beta-adrenergic blockage to the treatment of the traumatic brain injury lessens mortality. The basis for conducting this study was established by retrospective data showing no harm to patients receiving Inderal and potential benefit. Available data, including data from the University of Tennessee, are retrospective and are limited to simple exposure to the drug. The proposed study will attempt to further quantify the effect by dosing with the drug to actual beta-blockade instead of simple exposure to the drug.

The effect of propranolol at the dosing levels used in this research will be determined by measurement of urinary catecholamines in both study arms and comparison of the actual effect of the drug on the catecholamine surge that occurs following traumatic brain injury will be determined.

Additionally, the effect of healthcare disparities on outcomes in patients with traumatic brain injury will be measured. Outcomes will be stratified by payer status and ethnicity to determine the effect each of these variables has on outcomes.

Eligibility criteria: Inclusion Criteria:

* Subjects ages 18 and older with isolated traumatic brain injury as defined by Glasgow Coma Scale score 12 or less with documented injury on head CT and limited injury to the rest of the body. (Abbreviated Injury Scale (AIS) must be \< or = 3 from other body areas.)

Exclusion Criteria:

* Subjects \<18 years of age, prisoners, those on beta-blockers as home medication, those who are pregnant, those with severe liver disease, those taking vasopressors, those with acute coronary syndrome, and those with severe injury to another body region (AIS \>3).
* Subjects who cannot be enrolled within 48 hours of admission following acute resuscitation will not be enrolled into this study.

Primary outcomes:
measure: Mortality
timeFrame: 30 day
Secondary outcomes:
measure: Urine Catecholamine Levels
timeFrame: Collected at baseline, Day 2, Day 5, Day 10 and Day 14.
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Regional One Health
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Thomas J. Schroeppel, MD
role: PRINCIPAL_INVESTIGATOR
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