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| ID | Type | Description | Link |
|---|---|---|---|
| NIH RO1GM056687 | Other Grant/Funding Number | NIH |
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Shriner's Burn Hospital closed the study and access to study-related data is unavailable. We are unable to submit the additional information or results-data
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
| Shriners Hospitals for Children | OTHER |
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The proposed study will test the hypothesis that Propranolol, fenofibrate and fenofibrate plus propranolol have therapeutic, physiological, and metabolic effects that will improve clinical outcomes, and the long-term recovery, rehabilitation, and QOL in burned patients.
Determine the clinical benefits and underlying mechanisms whereby the metabolic perturbators fenofibrate and propranolol impact burn patient outcomes. The investigators hypothesize that these metabolic regulators given for one year will maintain body mass, improve muscle function by increasing protein synthesis, augment wound healing, reduce fibrosis, improve cardiovascular function, reduce systemic inflammation, restore insulin sensitivity, and decrease liver dysfunction without the risk of the hypoglycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenofibrate | Active Comparator | Fenofibrate by mouth given daily throughout hospitalization for up to 12 months |
|
| Fenofibrate and Propranolol | Active Comparator | Fenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months |
|
| Placebo | Placebo Comparator | Placebo by mouth given daily throughout hospitalization for up to 12 months. |
|
| Propranolol | Active Comparator | Propranolol by mouth given throughout hospitalization for up to 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate | Drug | Fenofibrate by mouth given daily throughout hospitalization for up to 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Metabolism | Glucose levels and amount of regular insulin infused during hospitalization. | From randomization up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Hypermetabolism | Resting energy expenditure (REE) done weekly while in hospital | From randomization up to one year |
| Rate pressure product | Multiply the subjects resting heart rate and systolic blood pressure measurements and average every 24 hours while hospitalized |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy
History or existence of pre-burn injury conditions
Decision not to treat due to burn injury severity or futility as deemed by the clinical team
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| Name | Affiliation | Role |
|---|---|---|
| David N Herndon, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospitals for Children | Galveston | Texas | 77551 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2023 | |
| Reset | Jul 3, 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 3, 2023 | |||
| Mar 27, 2026 |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| D011433 | Propranolol |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo | Drug | Placebo by mouth given daily throughout hospitalization for up to 12 months |
|
|
| Propranolol | Drug | Propranolol by mouth given daily throughout hospitalization for up to 12 months |
|
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| Participants will be followed for the duration of hospital stay, an average of 5 weeks |
| Apr 16, 2026 |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |