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Purpose

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

Condition

Eligibility

Eligible Ages
Under 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Propranolol 		Propranolol by mouth given daily throughout hospitalization for up to 12 months
  • Drug: Propranolol
    Propranolol by mouth given daily throughout hospitalization for up to 12 months
    Other names:
    • Metoprolol
    • inderal
Placebo Comparator
Sugar Pill 		Placebo by mouth given daily throughout hospitalization for up to 12 months
  • Drug: Placebo
    Placebo by mouth given daily throughout hospitalization for up to 12 months.
    Other names:
    • Control

More Details

Status
Terminated
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.