Safety and Efficacy of Propranolol in Severely Burned Children
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product
研究概览
简要总结
To determine the safety and efficacy of administration of propranolol for reducing heart rate and blood pressure in burn injury.
详细描述
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.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnancy
- •Known history of AIDS, Aids Related Complex, or HIV
- •History of cancer within 5 years
- •Existence of pre-morbid conditions
- •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
研究组 & 干预措施
Propranolol
Propranolol by mouth given daily throughout hospitalization for up to 12 months
干预措施: Propranolol (Drug)
Sugar Pill
Placebo by mouth given daily throughout hospitalization for up to 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product
时间窗: 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)
次要结局
- Number of deaths(time of randomization up to one year)