A Phase 2 interventional study of Propranolol in Trauma, sponsored by Denver Health and Hospital Authority. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-15.
Sponsored by Denver Health and Hospital Authority · Phase 2, Interventional, and Treatment
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 15 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Denver Health and Hospital Authority is the lead sponsor of 84 studies on the registry; 4 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria Include:
Drug: Propranolol
Change in REE vs. Controls
Time frame: ICU admission date to ICU discharge or death
Changes in Protein Metabolism Measurements
net nitrogen balance, fat-free mass, and fat mass
Time frame: ICU admission date to ICU discharge or death
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
Clinical Outcome Measurements
Ventilator days, ICU and hospital days, and in-hospital mortality
Time frame: ICU admission date to ICU discharge or death
| Milestone | Propranol Treatment | Standard of Care |
|---|---|---|
| Started | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 0 | 0 |
No measurements were reported for this outcome.
net nitrogen balance, fat-free mass, and fat mass
No measurements were reported for this outcome.
blood glucose levels, insulin requirements, cortisol levels, IL-6 and IL-10 levels, infection rates, and organ dysfunction
No measurements were reported for this outcome.
Ventilator days, ICU and hospital days, and in-hospital mortality
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propranol Treatment | — | — | — |
| Standard of Care | — | — | — |
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.
| Age, Categorical | Propranol Treatment | Standard of Care | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Age, Continuous | Propranol Treatment | Standard of Care | Total |
|---|
| Sex: Female, Male | Propranol Treatment | Standard of Care | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race (NIH/OMB) | Propranol Treatment | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | — | — |
| Asian | — | — | — |
| Native Hawaiian or Other Pacific Islander | — | — | — |
| Black or African American | — | — | — |
| White | — | — | — |
| More than one race | — | — | — |
| Unknown or Not Reported | — | — | — |
| Region of Enrollment(participants) | Propranol Treatment | Standard of Care | Total |
|---|
This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Denver Health and Hospital Authority