Beta Blockade in Critical Injury

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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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)

More Information

• Responsible Party: Denver Health and Hospital Authority
• ClinicalTrials.gov Identifier: NCT00356187
• Other Study ID Numbers: R03 DK73349 (completed); R03DK073349 ( U.S. NIH Grant/Contract )
• First Posted: July 25, 2006
• 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:

Wounds and Injuries; 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