Study Stopped
At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.
Propranolol in Severely Burned Children
Safety and Efficacy of Propranolol in Severely Burned Children
1 other identifier
interventional
63
1 country
4
Brief Summary
To determine the safety and efficacy of administration of propranolol for reducing heart rate and blood pressure in burn injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2013
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2019
CompletedSeptember 24, 2019
August 1, 2018
5 years
September 4, 2013
September 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product
Multiply the subjects resting heart rate and systolic blood pressure measurements and average every 24 hours while hospitalized (an average of 4 weeks)
Measured during acute hospital stay, an average of 4 weeks.
Secondary Outcomes (1)
Number of deaths
time of randomization up to one year
Study Arms (2)
Propranolol
ACTIVE COMPARATORPropranolol by mouth given daily throughout hospitalization for up to 12 months
Sugar Pill
PLACEBO COMPARATORPlacebo by mouth given daily throughout hospitalization for up to 12 months
Interventions
Propranolol by mouth given daily throughout hospitalization for up to 12 months
Placebo by mouth given daily throughout hospitalization for up to 12 months.
Eligibility Criteria
You may qualify if:
- Burns covering \>20% of the total body surface are
- Age of 0 to 18 years
- Patient arrival to the burn center within 96 hours (4 days) of burn injury
- Require \> 1 surgical procedure
You may not qualify if:
- Pregnancy
- Known history of AIDS, Aids Related Complex, or HIV
- History of cancer within 5 years
- Existence of pre-morbid conditions
- Asthma
- Congestive heart failure (measured ejection fraction \< 20%)
- Medical condition requiring glucocorticoid treatment
- Burn injury due to chemical burns
- Burn injury due to deep electrical injury (decision of hospital PI)
- Presence of anoxic brain injury that is not expected to result in complete recovery
- Decision not to treat due to burn injury severity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Shriners Hospitals for Children
Sacramento, California, 95817, United States
Shriners Hospitals for Children
Boston, Massachusetts, 02114, United States
Shriners Hospitals for Children
Cincinnati, Ohio, 45229, United States
Shriners Hospitals for Children
Galveston, Texas, 77551, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David N Herndon, MD
University of Texas
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2013
First Posted
October 8, 2013
Study Start
December 1, 2013
Primary Completion
December 1, 2018
Study Completion
April 23, 2019
Last Updated
September 24, 2019
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share