Beta Blockade in Critical Injury

Phase 2

Terminated

• Conditions: Trauma
• Interventions: Drug: Propranolol

• Registration Number: NCT00356187
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-15
• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-24
• Study First Posted: 2006-07-25
• Primary Completion: 2009-01-31
• Study Completion: 2009-01-31
• Results First Submitted: 2018-01-09
• Results First Submitted QC: 2018-01-09
• Status Verified: 2018-02
• Results First Posted: 2018-02-07
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propranol Treatment	Propranolol	-

Primary Outcome Measures

Name	Time	Method
Change in REE vs. Controls	ICU admission date to ICU discharge or death

Secondary Outcome Measures

Name	Time	Method
Changes in Protein Metabolism Measurements	ICU admission date to ICU discharge or death	net nitrogen balance, fat-free mass, and fat mass
Alterations in Neuroendocrine and Immunoinflammatory Measurements	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
Clinical Outcome Measurements	ICU admission date to ICU discharge or death	Ventilator days, ICU and hospital days, and in-hospital mortality

Trial Locations

Locations (1)

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States