Protective Effects of Propranolol in Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Protective Effects of Propranolol in Adults Following Major Burn Injury: A Safety and Efficacy Trial

Conditions
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Burn

Intervention / Treatment
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* Drug: Propranolol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propranolol<br>Propranolol by mouth given daily throughout hospitalization | Drug: Propranolol<br>* Propranolol by mouth given daily throughout hospitalization<br>* Other names: inderol;|
| Placebo Comparator: Sugar Pill<br>Placebo by mouth given daily throughout hospitalization | Drug: Placebo<br>* Placebo by mouth given daily throughout hospitalization<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac rate pressure product | Multiply the subjects resting heart rate and blood pressure measurements as the average per 24 hours | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rates | mortality rates will be compared between placebo group and propranolol treatment groups | time of randomization up to one year |