Propranolol in Severely Burned Children

NCT ID: NCT01957449

Last Updated: 2019-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2019-04-23

Brief Summary

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

Detailed Description

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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.

Conditions

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Burn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Propranolol

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

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type DRUG

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

Sugar Pill

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Propranolol

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Metoprolol inderal Control

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David N Herndon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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Shriners Hospitals for Children

Sacramento, California, United States

Site Status

Shriners Hospitals for Children

Boston, Massachusetts, United States

Site Status

Shriners Hospitals for Children

Cincinnati, Ohio, United States

Site Status

Shriners Hospitals for Children

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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13-103

Identifier Type: -

Identifier Source: org_study_id

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