NCT01902810

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2013

Longer than P75 for phase_2

Geographic Reach
2 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2019

Completed
Last Updated

November 29, 2019

Status Verified

August 1, 2018

Enrollment Period

5.9 years

First QC Date

June 24, 2013

Last Update Submit

November 26, 2019

Conditions

Burn

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mortality rates

    time of randomization up to one year

Study Arms (2)

Propranolol

ACTIVE COMPARATOR

Propranolol by mouth given daily throughout hospitalization

Drug: Propranolol

Sugar Pill

PLACEBO COMPARATOR

Placebo by mouth given daily throughout hospitalization

Drug: Placebo

Interventions

PropranololDRUG

Propranolol by mouth given daily throughout hospitalization

Also known as: metoprolol, inderol
Propranolol
PlaceboDRUG

Placebo by mouth given daily throughout hospitalization

Also known as: control
Sugar Pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Florida

Gainesville, Florida, 32610, United States

Location

Loyola University Burn Center

Maywood, Illinois, 60153, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Cornell Burn Center

New York, New York, 10065, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Texas, Southwestern

Dallas, Texas, 75390, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77551, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

University of Toronto

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Burns

Interventions

PropranololMetoprolol

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • David N Herndon, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2013

First Posted

July 18, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2019

Study Completion

July 12, 2019

Last Updated

November 29, 2019

Record last verified: 2018-08

Locations

CA(1)US(9)