Trauma
Conditions
Brief summary
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.
Interventions
DRUGPropranolol
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ISS\>25, stable at 48 hours after injury * Fully resuscitated * Ventilated
Exclusion criteria
Include: * Intracranial hypertension requiring active treatment * Hypotension/Pressors * Already on beta blocker for a standard indication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in REE vs. Controls | ICU admission date to ICU discharge or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Protein Metabolism Measurements | ICU admission date to ICU discharge or death | net nitrogen balance, fat-free mass, and fat mass |
| Alterations in Neuroendocrine and Immunoinflammatory Measurements | ICU admission date to ICU discharge or death | blood glucose levels, insulin requirements, cortisol levels, IL-6 and IL-10 levels, infection rates, and organ dysfunction |
| Clinical Outcome Measurements | ICU admission date to ICU discharge or death | Ventilator days, ICU and hospital days, and in-hospital mortality |
Countries
United States
Participant flow
Pre-assignment details
Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention.
Participants by arm
| Arm | Count |
|---|---|
| Propranol Treatment Propranolol | 0 |
| 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 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in REE vs. Controls
Time frame: ICU admission date to ICU discharge or death
Population: 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.
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
Time frame: ICU admission date to ICU discharge or death
Population: 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.
Secondary
Changes in Protein Metabolism Measurements
net nitrogen balance, fat-free mass, and fat mass
Time frame: ICU admission date to ICU discharge or death
Population: 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.
Secondary
Clinical Outcome Measurements
Ventilator days, ICU and hospital days, and in-hospital mortality
Time frame: ICU admission date to ICU discharge or death
Population: 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.