Clinical trial NCT01902810: Protective Effects of Propranolol in Adults
Official title: Protective Effects of Propranolol in Adults Following Major Burn Injury: A Safety and Efficacy Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Burn
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: American Burn Association
First posted: 2013-07-18
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac rate pressure product
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes:
measure: Mortality rates
timeFrame: time of randomization up to one year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Maywood
country: United States
facility: Loyola University Burn Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Cornell Burn Center
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Dallas
country: United States
facility: University of Texas, Southwestern
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Texas
name: David N Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References: