Protective Effects of Propranolol in Adults

• Status: Terminated
• Trial end date: 2019-07-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: American Burn Association; United States Department of Defense
• Treatments: Metoprolol; Propranolol

Criteria

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