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Beta Blockade in Critical Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00356187
First Posted: July 25, 2006
Last Update Posted: March 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356187


Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

ClinicalTrials.gov Identifier: NCT00356187     History of Changes
Other Study ID Numbers: R03 DK73349 (completed)
First Submitted: July 24, 2006
First Posted: July 25, 2006
Last Update Posted: March 18, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents