Propranolol in Severely Burned Children

Phase 3TerminatedNCT01957449

The University of Texas Medical Branch, Galveston63 enrolled

Overview

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

Other purposes of this study are to study the effect on muscle function, the infectious process, sepsis, systemic inflammation and long-term scarring. Quality of life will also be looked at over time.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Burn

Interventions

PropranololDRUG

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

PlaceboDRUG

Placebo by mouth given daily throughout hospitalization for up to 12 months.

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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, 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

Locations (4)

Shriners Hospitals for Children

Sacramento, California, United States

Shriners Hospitals for Children

Boston, Massachusetts, United States

Shriners Hospitals for Children

Cincinnati, Ohio, United States

Shriners Hospitals for Children

Galveston, Texas, United States

Outcomes

Primary Outcomes

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)

Time frame: Measured during acute hospital stay, an average of 4 weeks.

Secondary Outcomes

Number of deaths

Number of deaths will be compared between placebo group and propranolol treatment groups.

Time frame: time of randomization up to one year

Data from ClinicalTrials.gov

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