Beta Blockade in Critical Injury

Trauma Clinical Trial

Official title:

Beta-blockade Reduces Catabolism in Severely Injured Trauma Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00356187
• Other study ID #: R03 DK73349 (completed)
• Secondary ID: R03DK073349
• Status: Terminated
• Phase: Phase 2
• First received: July 24, 2006
• Last updated: February 20, 2018
• Start date: February 15, 2006
• Est. completion date: January 31, 2009

Study information

• Verified date: February 2018
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Trauma

Intervention

Drug:
• Propranolol

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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