Propranolol in Severely Burned Children

Safety and Efficacy of Propranolol in Severely Burned Children

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

Study Overview

• Status: Terminated
• Conditions: Burn
• Intervention / Treatment: Drug: Propranolol; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Shriners Hospitals for Children
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Shriners Hospitals for Children
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Shriners Hospitals for Children
  • Texas
    • Galveston, Texas, United States, 77551
      • Shriners Hospitals for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of deaths	Number of deaths will be compared between placebo group and propranolol treatment groups.	time of randomization up to one year

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Shriners Hospitals for Children

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): April 23, 2019

Study Registration Dates

• First Submitted: September 4, 2013
• First Submitted That Met QC Criteria: September 30, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Propranolol; Metoprolol
• Other Study ID Numbers: 13-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No