Status:
TERMINATED
Protective Effects of Propranolol in Adults
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Collaborating Sponsors:
United States Department of Defense
American Burn Association
Conditions:
Burn
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 si...
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 tre...
Eligibility Criteria
Inclusion
- ≥ 20% Total Body Surface Area (TBSA) burn with anticipated operation need on admission
- Age ≥ 18 years
- Admission within 72 hours of injury
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2019
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01902810
Start Date
July 1 2013
End Date
July 12 2019
Last Update
November 29 2019
Active Locations (10)
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1
University of Florida
Gainesville, Florida, United States, 32610
2
Loyola University Burn Center
Maywood, Illinois, United States, 60153
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114