Protective Effects of Propranolol in Adults
Purpose
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.
Condition
- Burn
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Propranolol |
Propranolol by mouth given daily throughout hospitalization |
|
Placebo Comparator Sugar Pill |
Placebo by mouth given daily throughout hospitalization |
|
More Details
- Status
- Terminated
- Sponsor
- The University of Texas Medical Branch, Galveston
Study Contact
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.