Protective Effects of Propranolol in Adults

The University of Texas System (UT)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Burn

Treatments: Drug: Propranolol; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01902810

12-205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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47 participants in 2 patient groups, including a placebo group

Propranolol

Active Comparator group

Description:

Propranolol by mouth given daily throughout hospitalization

Treatment:

Drug: Propranolol

Sugar Pill

Placebo Comparator group

Description:

Placebo by mouth given daily throughout hospitalization

Treatment:

Drug: Placebo