Trauma Clinical Trial
Official title:
Beta-blockade Reduces Catabolism in Severely Injured Trauma Patients
Verified date | February 2018 |
Source | Denver Health and Hospital Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 15 |
Est. completion date | January 31, 2009 |
Est. primary completion date | January 31, 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Denver Health Medical Center | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
Denver Health and Hospital Authority | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in REE vs. Controls | ICU admission date to ICU discharge or death | ||
Secondary | Changes in Protein Metabolism Measurements | net nitrogen balance, fat-free mass, and fat mass | 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 | ICU admission date to ICU discharge or death | |
Secondary | Clinical Outcome Measurements | Ventilator days, ICU and hospital days, and in-hospital mortality | ICU admission date to ICU discharge or death |
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