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

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

ArmDescriptionAssigned Intervention
Active Comparator
Propranolol
Propranolol by mouth given daily throughout hospitalization
  • Drug: Propranolol
    Propranolol by mouth given daily throughout hospitalization
    Other names:
    • metoprolol
    • inderol
Placebo Comparator
Sugar Pill
Placebo by mouth given daily throughout hospitalization
  • Drug: Placebo
    Placebo by mouth given daily throughout hospitalization
    Other names:
    • control

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.