Burn | Protective Effects of Propranolol in Adults
Burn research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PropranololPropranolol by mouth given daily throughout hospitalization
Drug:PlaceboPlacebo by mouth given daily throughout hospitalization
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PropranololPropranolol by mouth given daily throughout hospitalization
Sugar PillPlacebo by mouth given daily throughout hospitalization
Start Date: July 2013
Completed Date: December 2019
Phase: Phase 2/Phase 3
Primary Outcome: Cardiac rate pressure product
Secondary Outcome: Mortality rates
Study sponsors, principal investigator, and references
Principal Investigator: David N Herndon, MD
Lead Sponsor: The University of Texas Medical Branch, Galveston
Collaborator: United States Department of Defense