Trial | NCT01902810  Report issue

Title

Protective Effects of Propranolol in Adults
Protective Effects of Propranolol in Adults Following Major Burn Injury: A Safety and Efficacy Trial

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Indication/Condition

    Burn

  • Intervention/Treatment

    propranolol ...

  • Study Participants

    47
This efficacy and safety trial will examine the effects and safety of propranolol administered to adult patients with severe burn injury. The investigators hypothesize that propranolol will provide significant benefit to adults following severe burn injury at doses that are safe and do not increase risk of adverse infectious and non-infectious outcomes.
A safety and efficacy trial is needed in order to determine the safety of propranolol treatment in adult burn patients, identify which subpopulations may be most likely to benefit from propranolol treatment and to identify propranolol dose levels that are not only safe but potentially effective.
Study Started
Jul 31
2013
Primary Completion
Jun 30
2019
Study Completion
Jul 12
2019
Last Update
Nov 29
2019

Drug Propranolol

Propranolol by mouth given daily throughout hospitalization

  • Other names: metoprolol, inderol

Drug Placebo

Placebo by mouth given daily throughout hospitalization

  • Other names: control

Propranolol Active Comparator

Propranolol by mouth given daily throughout hospitalization

Sugar Pill Placebo Comparator

Placebo by mouth given daily throughout hospitalization

Criteria 

Inclusion Criteria:

≥ 20% Total Body Surface Area (TBSA) burn with anticipated operation need on admission
Age ≥ 18 years
Admission within 72 hours of injury

Exclusion Criteria:

Age <18
Patients unlikely to survive injury or with ;age = total burn size ≥ 130
Electrical or deep chemical burn
Malignancy currently undergoing treatment or history of cancer treatment within 5 years
History of HIV or AIDS
Presence of anoxic brain injury that is not expected to result in complete recovery
Currently treated for Chronic Obstructive Pulmonary Disease (COPD), asthma or other chronic pulmonary conditions
History of Congestive Heart Failure (CHF) (ejection fraction < 20%)
Pre-injury medications including blocking agents (alpha or beta) or other anti-arrhythmic drugs
Pregnant women
Prisoners
History of cardiac arrhythmia requiring medication
Medical condition requiring glucocorticoid treatment
Patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
No Results Posted