Protective Effects of Propranolol in Adults

Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01902810
• Other study ID #: 12-205
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: July 2013
• Est. completion date: July 12, 2019

Study information

• Verified date: August 2018
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: July 12, 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burn
• Burns

Intervention

Drug:
• Propranolol
Propranolol by mouth given daily throughout hospitalization
• Placebo
Placebo by mouth given daily throughout hospitalization

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio
United States	University of Texas, Southwestern	Dallas	Texas
United States	University of Florida	Gainesville	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Loyola University Burn Center	Maywood	Illinois
United States	Cornell Burn Center	New York	New York
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	American Burn Association, United States Department of Defense

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality rates	mortality rates will be compared between placebo group and propranolol treatment groups	time of randomization up to one year