Protective Effects of Propranolol in Adults

Phase 2

Terminated

• Conditions: Burn
• Interventions: Drug: Placebo; Drug: Propranolol

• Registration Number: NCT01902810
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief 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.

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.

Study Timeline

• Study First Submitted: 2013-06-24
• Study Start: 2013-07
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-18
• Status Verified: 2018-08
• Primary Completion: 2019-06
• Study Completion: 2019-07-12
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar Pill	Placebo	Placebo by mouth given daily throughout hospitalization
Propranolol	Propranolol	Propranolol by mouth given daily throughout hospitalization

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mortality rates	time of randomization up to one year	mortality rates will be compared between placebo group and propranolol treatment groups

Trial Locations

Locations (10)

University of Florida; 🇺🇸 Gainesville, Florida, United States

Cornell Burn Center; 🇺🇸 New York, New York, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Loyola University Burn Center; 🇺🇸 Maywood, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Texas, Southwestern; 🇺🇸 Dallas, Texas, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

University of Toronto; 🇨🇦 Toronto, Ontario, Canada