Beta Blockade in Critical Injury

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00356187
First received: July 24, 2006
Last updated: March 17, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Trauma
Drug: Propranolol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Beta-blockade Reduces Catabolism in Severely Injured Trauma Patients

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Lean body mass
  • ICU length of stay
  • Infectious complications

Secondary Outcome Measures:
  • Metabolic rate
  • Glucose control
  • Nitrogen Balance

Estimated Enrollment: 100
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356187

Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00356187     History of Changes
Other Study ID Numbers: R03 DK73349 (completed)
Study First Received: July 24, 2006
Last Updated: March 17, 2010
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 29, 2014