Burn
Conditions
Brief summary
This efficacy and safety trial will examine the effects and safety of propranolol administered to adult patients with severe burn injury. The investigators hypothesize that propranolol will provide significant benefit to adults following severe burn injury at doses that are safe and do not increase risk of adverse infectious and non-infectious outcomes.
Detailed description
A safety and efficacy trial is needed in order to determine the safety of propranolol treatment in adult burn patients, identify which subpopulations may be most likely to benefit from propranolol treatment and to identify propranolol dose levels that are not only safe but potentially effective.
Interventions
DRUGPropranolol
Propranolol by mouth given daily throughout hospitalization
DRUGPlacebo
Placebo by mouth given daily throughout hospitalization
Sponsors
United States Department of Defense
American Burn Association
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 20% Total Body Surface Area (TBSA) burn with anticipated operation need on admission * Age ≥ 18 years * Admission within 72 hours of injury
Exclusion criteria
* Age \<18 * Patients unlikely to survive injury or with ;age = total burn size ≥ 130 * Electrical or deep chemical burn * Malignancy currently undergoing treatment or history of cancer treatment within 5 years * History of HIV or AIDS * Presence of anoxic brain injury that is not expected to result in complete recovery * Currently treated for Chronic Obstructive Pulmonary Disease (COPD), asthma or other chronic pulmonary conditions * History of Congestive Heart Failure (CHF) (ejection fraction \< 20%) * Pre-injury medications including blocking agents (alpha or beta) or other anti-arrhythmic drugs * Pregnant women * Prisoners * History of cardiac arrhythmia requiring medication * Medical condition requiring glucocorticoid treatment * Patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac rate pressure product | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | Multiply the subjects resting heart rate and blood pressure measurements as the average per 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rates | time of randomization up to one year | mortality rates will be compared between placebo group and propranolol treatment groups |
Countries
Canada, United States
Outcome results
None listed