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At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| American Burn Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol | Active Comparator | Propranolol by mouth given daily throughout hospitalization |
|
| Sugar Pill | Placebo Comparator | Placebo by mouth given daily throughout hospitalization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol | Drug | Propranolol by mouth given daily throughout hospitalization |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David N Herndon, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| Loyola University Burn Center |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2023 | |
| Reset | Jul 5, 2023 | |
| Release | Mar 27, 2026 | |
| Reset | Apr 16, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2023 | Jul 5, 2023 | |||
| Mar 27, 2026 |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Placebo | Drug | Placebo by mouth given daily throughout hospitalization |
|
|
| Maywood |
| Illinois |
| 60153 |
| United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Cornell Burn Center | New York | New York | 10065 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Texas, Southwestern | Dallas | Texas | 75390 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77551 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| University of Toronto | Toronto | Ontario | M4N 3M5 | Canada |
| Apr 16, 2026 |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |