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Propranolol in Severely Burned Children

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ClinicalTrials.gov Identifier: NCT01957449
Recruitment Status : Terminated (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.)
First Posted : October 8, 2013
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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

Condition or disease Intervention/treatment Phase
Burn Drug: Propranolol Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Propranolol in Severely Burned Children
Actual Study Start Date : December 2013
Actual Primary Completion Date : December 2018
Actual Study Completion Date : April 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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 Name: Control




Primary Outcome Measures :
  1. Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product [ Time Frame: Measured during acute hospital stay, an average of 4 weeks. ]
    Multiply the subjects resting heart rate and systolic blood pressure measurements and average every 24 hours while hospitalized (an average of 4 weeks)


Secondary Outcome Measures :
  1. Number of deaths [ Time Frame: time of randomization up to one year ]
    Number of deaths will be compared between placebo group and propranolol treatment groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957449


Locations
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United States, California
Shriners Hospitals for Children
Sacramento, California, United States, 95817
United States, Massachusetts
Shriners Hospitals for Children
Boston, Massachusetts, United States, 02114
United States, Ohio
Shriners Hospitals for Children
Cincinnati, Ohio, United States, 45229
United States, Texas
Shriners Hospitals for Children
Galveston, Texas, United States, 77551
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Shriners Hospitals for Children
Investigators
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Principal Investigator: David N Herndon, MD University of Texas

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT01957449     History of Changes
Other Study ID Numbers: 13-103
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents