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Protective Effects of Propranolol in Adults

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ClinicalTrials.gov Identifier: NCT01902810
Recruitment Status : Recruiting
First Posted : July 18, 2013
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
United States Department of Defense
American Burn Association
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
This efficacy and safety trial will examine the effects and safety of propranolol administered to adult patients with severe burn injury. The investigators hypothesize that propranolol will provide significant benefit to adults following severe burn injury at doses that are safe and do not increase risk of adverse infectious and non-infectious outcomes.

Condition or disease Intervention/treatment Phase
Burn Drug: Propranolol Drug: Placebo Phase 2 Phase 3

Detailed Description:
A safety and efficacy trial is needed in order to determine the safety of propranolol treatment in adult burn patients, identify which subpopulations may be most likely to benefit from propranolol treatment and to identify propranolol dose levels that are not only safe but potentially effective.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protective Effects of Propranolol in Adults Following Major Burn Injury: A Safety and Efficacy Trial
Study Start Date : July 2013
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Active Comparator: Propranolol
Propranolol by mouth given daily throughout hospitalization
Drug: Propranolol
Propranolol by mouth given daily throughout hospitalization
Other Names:
  • metoprolol
  • inderol

Placebo Comparator: Sugar Pill
Placebo by mouth given daily throughout hospitalization
Drug: Placebo
Placebo by mouth given daily throughout hospitalization
Other Name: control




Primary Outcome Measures :
  1. Cardiac rate pressure product [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
    Multiply the subjects resting heart rate and blood pressure measurements as the average per 24 hours


Secondary Outcome Measures :
  1. Mortality rates [ Time Frame: time of randomization up to one year ]
    mortality rates will be compared between placebo group and propranolol treatment groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 20% Total Body Surface Area (TBSA) burn with anticipated operation need on admission
  • Age ≥ 18 years
  • Admission within 72 hours of injury

Exclusion Criteria:

  • Age <18
  • Patients unlikely to survive injury or with ;age = total burn size ≥ 130
  • Electrical or deep chemical burn
  • Malignancy currently undergoing treatment or history of cancer treatment within 5 years
  • History of HIV or AIDS
  • Presence of anoxic brain injury that is not expected to result in complete recovery
  • Currently treated for Chronic Obstructive Pulmonary Disease (COPD), asthma or other chronic pulmonary conditions
  • History of Congestive Heart Failure (CHF) (ejection fraction < 20%)
  • Pre-injury medications including blocking agents (alpha or beta) or other anti-arrhythmic drugs
  • Pregnant women
  • Prisoners
  • History of cardiac arrhythmia requiring medication
  • Medical condition requiring glucocorticoid treatment
  • Patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives

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): NCT01902810


Contacts
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Contact: Catherine Reed, RN 409-7706987 ca2reed@utmb.edu
Contact: Deb Benjamin, RN 409-770-6731 dbenjami@utmb.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: David Mozingo, MD       mozindw@surgery.ufl.edu   
Principal Investigator: David Mozingo, MD         
United States, Illinois
Loyola University Burn Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Richard Gamelli, MD       rgamelli@lumc.edu   
Principal Investigator: Richard Gamelli, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: G Patrick Kealey, MD       gerald-kealey@uiowa.edu   
Principal Investigator: G Patrick Kealey, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Shawn Fagan, MD       Sfagan@partners.org   
Principal Investigator: Shawn Fagan, MD         
United States, New York
Cornell Burn Center Recruiting
New York, New York, United States, 10065
Contact: Joe Bessey, MD       pbb2001@cornell.edu   
Principal Investigator: Joe Bassey, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Sidney Miller, MD       Sidney.Miller@osumc.edu   
Principal Investigator: Sidney Miller, MD         
United States, Texas
University of Texas, Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Steven Wolf, MD       steven.wolf@utsouthwestern.edu   
Principal Investigator: Steven Wolf, MD         
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77551
Contact: Deb Benjamin, RN    409-770-6731    Dbenjami@utmb.edu   
Contact: Cathy L Reed, BSN    409-770-6987    ca2reed@utmb.edu   
Principal Investigator: David Herndon, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Tam Pham, MD       tpham94@uw.edu   
Principal Investigator: Tam Pham, MD         
Canada, Ontario
University of Toronto Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Marc Jeschke, MD       Marc.Jeschke@sunnybrook.ca   
Principal Investigator: Marc Jeschke, MD         
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
United States Department of Defense
American Burn Association
Investigators
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Principal Investigator: David N Herndon, MD University of Texas

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT01902810     History of Changes
Other Study ID Numbers: 12-205
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Propranolol
Burns
Wounds and Injuries
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