Protective Effects of Propranolol in Adults

Protective Effects of Propranolol in Adults Following Major Burn Injury: A Safety and Efficacy Trial

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.

Study Overview

• Status: Terminated
• Conditions: Burn
• Intervention / Treatment: Drug: Propranolol; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • University of Toronto
• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Burn Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University OF Iowa
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New York
    • New York, New York, United States, 10065
      • Cornell Burn Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas, Southwestern
    • Galveston, Texas, United States, 77551
      • University of Texas Medical Branch
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac rate pressure product	Multiply the subjects resting heart rate and blood pressure measurements as the average per 24 hours	participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rates	mortality rates will be compared between placebo group and propranolol treatment groups	time of randomization up to one year

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: United States Department of Defense; American Burn Association

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2013
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): July 12, 2019

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: July 17, 2013
• First Posted (ESTIMATE): July 18, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Propranolol; Metoprolol
• Other Study ID Numbers: 12-205