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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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