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TerminatedNCT01957449Updated Sep 24, 2019

Propranolol in Severely Burned Children

A Phase 2/3 interventional study of Propranolol and Placebo in Burn, sponsored by The University of Texas Medical Branch, Galveston. Terminated at 4 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2019-09-24.

Sponsored by The University of Texas Medical Branch, Galveston · Phase 2/3, Interventional, and Treatment

Why this study was 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.
Phase
Phase 2/3
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
Up to 18 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Burn
03

In context

Lead sponsor

The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
63 participants (actual)

Study arms

  • Active comparator
    Propranolol

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

    Drug: Propranolol

  • Placebo comparator
    Sugar Pill

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

    Drug: Placebo

Interventions

  • DrugPropranolol

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

    Also known as: Metoprolol, inderal

  • DrugPlacebo

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

    Also known as: Control

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

4 sites
  • Shriners Hospitals for Children
    Sacramento, California 95817, United States
  • Shriners Hospitals for Children
    Boston, Massachusetts 02114, United States
  • Shriners Hospitals for Children
    Cincinnati, Ohio 45229, United States
  • Shriners Hospitals for Children
    Galveston, Texas 77551, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01957449
Lead sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Shriners Hospitals for Children
Responsible party
Sponsor
First posted
Oct 8, 2013
Start date
Dec 2013
Primary completion
Dec 2018
Completion
Apr 23, 2019
Last update
Sep 24, 2019

Study contacts

David N Herndon, MD
principal investigator · University of Texas

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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