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Burn | Propranolol in Severely Burned Children

Burn research study

What is the primary objective of this study?

To determine the safety and efficacy of administration of propranolol for reducing heart rate and blood pressure in burn injury.

Who is eligible to participate?

Inclusion Criteria: - 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 Exclusion Criteria: - Pregnancy - Known history of AIDS, ARC, 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Burn

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PropranololPropranolol by mouth given daily throughout hospitalization for up to 12 months

Drug:PlaceboPlacebo by mouth given daily throughout hospitalization for up to 12 months.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PropranololPropranolol by mouth given daily throughout hospitalization for up to 12 months

Sugar PillPlacebo by mouth given daily throughout hospitalization for up to 12 months

Study Status

Recruiting

Start Date: December 2013

Completed Date: July 2018

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product

Secondary Outcome: Number of deaths

Study sponsors, principal investigator, and references

Principal Investigator: David N Herndon, MD

Lead Sponsor: The University of Texas Medical Branch, Galveston

Collaborator: Shriners Hospitals for Children

More information:https://clinicaltrials.gov/show/NCT01957449

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