Mechanisms of Fenofibrate and Propranolol Alone or Combined in Burn Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Glucose Metabolism
研究概览
简要总结
The proposed study will test the hypothesis that Propranolol, fenofibrate and fenofibrate plus propranolol have therapeutic, physiological, and metabolic effects that will improve clinical outcomes, and the long-term recovery, rehabilitation, and QOL in burned patients.
详细描述
Determine the clinical benefits and underlying mechanisms whereby the metabolic perturbators fenofibrate and propranolol impact burn patient outcomes. The investigators hypothesize that these metabolic regulators given for one year will maintain body mass, improve muscle function by increasing protein synthesis, augment wound healing, reduce fibrosis, improve cardiovascular function, reduce systemic inflammation, restore insulin sensitivity, and decrease liver dysfunction without the risk of the hypoglycemia.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •0 through 80 years
- •≥ 20% Total Body Surface Area Burn injury
排除标准
- •History or existence of pre-burn injury conditions
- •Allergies to propranolol or fenofibrate
- •Asthma requiring treatment
- •Congestive heart failure (measured ejection fraction < 20%)
- •Renal or hepatic disease
- •Medical condition requiring glucocorticoid treatment
- •History of AIDS, Aids Related Complex or HIV
- •History of Cancer within 5 years
- •Decision not to treat due to burn injury severity or futility as deemed by the clinical team
研究组 & 干预措施
Fenofibrate
Fenofibrate by mouth given daily throughout hospitalization for up to 12 months
干预措施: Fenofibrate (Drug)
Fenofibrate and Propranolol
Fenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months
干预措施: Fenofibrate (Drug)
Fenofibrate and Propranolol
Fenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months
干预措施: Propranolol (Drug)
Placebo
Placebo by mouth given daily throughout hospitalization for up to 12 months.
干预措施: Placebo (Drug)
Propranolol
Propranolol by mouth given throughout hospitalization for up to 12 months
干预措施: Propranolol (Drug)
结局指标
主要结局
Glucose Metabolism
时间窗: From randomization up to one year
Glucose levels and amount of regular insulin infused during hospitalization.
次要结局
- Hypermetabolism(From randomization up to one year)
- Rate pressure product(Participants will be followed for the duration of hospital stay, an average of 5 weeks)