Beta Blockade in in Traumatic Brain Injury
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/17/2018 |
| Start Date: | January 2016 |
| End Date: | May 2018 |
Beta-Adrenergic Blockade for Suppression of Catecholamine Surge Following Traumatic Brain Injury: A Randomized Trial
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.
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.
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.
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.
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.
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