Propranolol in Severely Burned Children

Burn Clinical Trial

Official title:

Safety and Efficacy of Propranolol in Severely Burned Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01957449
• Other study ID #: 13-103
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: December 2013
• Est. completion date: April 23, 2019

Study information

• Verified date: August 2018
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: April 23, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn

Intervention

Drug:
• Propranolol
Propranolol by mouth given daily throughout hospitalization for up to 12 months
• Placebo
Placebo by mouth given daily throughout hospitalization for up to 12 months.

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children	Boston	Massachusetts
United States	Shriners Hospitals for Children	Cincinnati	Ohio
United States	Shriners Hospitals for Children	Galveston	Texas
United States	Shriners Hospitals for Children	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of deaths	Number of deaths will be compared between placebo group and propranolol treatment groups.	time of randomization up to one year