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Beta Blockade in Critical Injury

Primary Purpose

Trauma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Propranolol
Sponsored by
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Denver Health Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Propranol Treatment

Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

Change in REE vs. Controls

Secondary Outcome Measures

Changes in Protein Metabolism Measurements
net nitrogen balance, fat-free mass, and fat mass
Alterations in Neuroendocrine and Immunoinflammatory Measurements
blood glucose levels, insulin requirements, cortisol levels, IL-6 and IL-10 levels, infection rates, and organ dysfunction
Clinical Outcome Measurements
Ventilator days, ICU and hospital days, and in-hospital mortality

Full Information

First Posted
July 24, 2006
Last Updated
February 20, 2018
Sponsor
Denver Health and Hospital Authority
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00356187
Brief Title
Beta Blockade in Critical Injury
Official Title
Beta-blockade Reduces Catabolism in Severely Injured Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment, end of funding
Study Start Date
February 15, 2006 (Actual)
Primary Completion Date
January 31, 2009 (Actual)
Study Completion Date
January 31, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propranol Treatment
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Propranolol
Primary Outcome Measure Information:
Title
Change in REE vs. Controls
Time Frame
ICU admission date to ICU discharge or death
Secondary Outcome Measure Information:
Title
Changes in Protein Metabolism Measurements
Description
net nitrogen balance, fat-free mass, and fat mass
Time Frame
ICU admission date to ICU discharge or death
Title
Alterations in Neuroendocrine and Immunoinflammatory Measurements
Description
blood glucose levels, insulin requirements, cortisol levels, IL-6 and IL-10 levels, infection rates, and organ dysfunction
Time Frame
ICU admission date to ICU discharge or death
Title
Clinical Outcome Measurements
Description
Ventilator days, ICU and hospital days, and in-hospital mortality
Time Frame
ICU admission date to ICU discharge or death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States

12. IPD Sharing Statement

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Beta Blockade in Critical Injury

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