Protective Effects of Propranolol in Adults Following Major Burn Injury: A Safety and Efficacy Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 10
- 主要终点
- Cardiac rate pressure product
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 20% Total Body Surface Area (TBSA) burn with anticipated operation need on admission
- •Age ≥ 18 years
- •Admission within 72 hours of injury
排除标准
- •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
研究组 & 干预措施
Propranolol
Propranolol by mouth given daily throughout hospitalization
干预措施: Propranolol (Drug)
Sugar Pill
Placebo by mouth given daily throughout hospitalization
干预措施: Placebo (Drug)
结局指标
主要结局
Cardiac rate pressure product
时间窗: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Multiply the subjects resting heart rate and blood pressure measurements as the average per 24 hours
次要结局
- Mortality rates(time of randomization up to one year)