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Beta Blockade in Critical Injury

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ClinicalTrials.gov Identifier: NCT00356187
Recruitment Status : Terminated (Slow enrollment, end of funding)
First Posted : July 25, 2006
Results First Posted : February 7, 2018
Last Update Posted : March 15, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Denver Health and Hospital Authority

Brief 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.

Condition or disease Intervention/treatment Phase
Trauma Drug: Propranolol Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beta-blockade Reduces Catabolism in Severely Injured Trauma Patients
Actual Study Start Date : February 15, 2006
Actual Primary Completion Date : January 31, 2009
Actual Study Completion Date : January 31, 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Propranol Treatment Drug: Propranolol
No Intervention: Standard of Care



Primary Outcome Measures :
  1. Change in REE vs. Controls [ Time Frame: ICU admission date to ICU discharge or death ]

Secondary Outcome Measures :
  1. Changes in Protein Metabolism Measurements [ Time Frame: ICU admission date to ICU discharge or death ]
    net nitrogen balance, fat-free mass, and fat mass

  2. Alterations in Neuroendocrine and Immunoinflammatory Measurements [ Time Frame: ICU admission date to ICU discharge or death ]
    blood glucose levels, insulin requirements, cortisol levels, IL-6 and IL-10 levels, infection rates, and organ dysfunction

  3. Clinical Outcome Measurements [ Time Frame: ICU admission date to ICU discharge or death ]
    Ventilator days, ICU and hospital days, and in-hospital mortality



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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

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

Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT00356187     History of Changes
Other Study ID Numbers: R03 DK73349 (completed)
R03DK073349 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2006    Key Record Dates
Results First Posted: February 7, 2018
Last Update Posted: March 15, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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