Beta Blockade in Critical Injury

NCT00356187 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: R03 DK73349 (completed)R03DK073349
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

• Change in REE vs. Controls

  ICU admission date to ICU discharge or death

Secondary Outcomes (3)

• Changes in Protein Metabolism Measurements

  ICU admission date to ICU discharge or death

• Alterations in Neuroendocrine and Immunoinflammatory Measurements

  ICU admission date to ICU discharge or death

• Clinical Outcome Measurements

  ICU admission date to ICU discharge or death

Study Arms (2)

Propranol Treatment

EXPERIMENTAL

Drug: Propranolol

Standard of Care

NO INTERVENTION

Interventions

Propranolol DRUG

Propranol Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ISS\>25, stable at 48 hours after injury
• Fully resuscitated
• Ventilated

You may not qualify if:

• Intracranial hypertension requiring active treatment
• Hypotension/Pressors
• Already on beta blocker for a standard indication

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Propranolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Elizabeth Kingsley, Senior Grants Analyst
• Organization: Denver Health and Hospital Authority

elizabeth.kingsley@dhha.org

3036027061

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 25, 2006
• Study Start: February 15, 2006
• Primary Completion: January 31, 2009
• Study Completion: January 31, 2009
• Last Updated: March 15, 2018
• Results First Posted: February 7, 2018

Record last verified: 2018-02

Locations

US (1)