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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK073349 | U.S. NIH Grant/Contract | View source |
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Slow enrollment, end of funding
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Critically injured patients endure a period of hypermetabolism/catabolism after being resuscitated. The metabolic cost of this may be measured in loss of lean body mass, poor wound healing, susceptibility to infection and long hospital stays. While there have been some data to suggest that hypermetabolism can be ameliorated in burn patients by beta blockade, to our knowledge, a prospective trial in trauma patients has not yet been done. Our hypothesis is that nonselective beta blockade will reduce catabolism, improve glucose control, blunt loss of lean body mass, decrease infections and improve outcome in a cohort of critically injured patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranol Treatment | Experimental |
| |
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in REE vs. Controls | ICU admission date to ICU discharge or death |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Protein Metabolism Measurements | net nitrogen balance, fat-free mass, and fat mass | ICU admission date to ICU discharge or death |
| Alterations in Neuroendocrine and Immunoinflammatory Measurements |
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Inclusion Criteria:
Exclusion Criteria Include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health Medical Center | Denver | Colorado | 80204 | United States |
Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Propranol Treatment | Propranolol |
| FG001 | Standard of Care | Results: 0 Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Insufficient enrollment to derive any results. Study closed in 2009 and is past the HIPAA data retention date. PI has left institution and does not have any access to any data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Propranol Treatment | Propranolol |
| BG001 | Standard of Care | Results: 0 Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in REE vs. Controls | Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data. | Posted | ICU admission date to ICU discharge or death |
|
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Insufficient enrollment to derive any results. Study closed in 2009 and is past the HIPAA data retention date. PI has left institution and does not have any access to any data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propranol Treatment | Propranolol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Kingsley, Senior Grants Analyst | Denver Health and Hospital Authority | 3036027061 | elizabeth.kingsley@dhha.org |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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blood glucose levels, insulin requirements, cortisol levels, IL-6 and IL-10 levels, infection rates, and organ dysfunction
| ICU admission date to ICU discharge or death |
| Clinical Outcome Measurements | Ventilator days, ICU and hospital days, and in-hospital mortality | ICU admission date to ICU discharge or death |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Secondary | Changes in Protein Metabolism Measurements | net nitrogen balance, fat-free mass, and fat mass | Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data. | Posted | ICU admission date to ICU discharge or death |
|
|
| Secondary | Alterations in Neuroendocrine and Immunoinflammatory Measurements | blood glucose levels, insulin requirements, cortisol levels, IL-6 and IL-10 levels, infection rates, and organ dysfunction | Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data. | Posted | ICU admission date to ICU discharge or death |
|
|
| Secondary | Clinical Outcome Measurements | Ventilator days, ICU and hospital days, and in-hospital mortality | Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data. | Posted | ICU admission date to ICU discharge or death |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard of Care | Results: 0 Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data. | 0 | 0 | 0 | 0 |
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| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |