Propranolol in Severely Burned Children

Phase 2

Terminated

• Conditions: Burn
• Interventions: Drug: Propranolol; Drug: Placebo

• Registration Number: NCT01957449
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-30
• Study First Posted: 2013-10-08
• Study Start: 2013-12
• Status Verified: 2018-08
• Primary Completion: 2018-12
• Study Completion: 2019-04-23
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propranolol	Propranolol	Propranolol by mouth given daily throughout hospitalization for up to 12 months
Sugar Pill	Placebo	Placebo by mouth given daily throughout hospitalization for up to 12 months

Primary Outcome Measures

Name	Time	Method
Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product	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

Name	Time	Method
Number of deaths	time of randomization up to one year	Number of deaths will be compared between placebo group and propranolol treatment groups.

Trial Locations

Locations (1)

Shriners Hospitals for Children; 🇺🇸 Galveston, Texas, United States