Role of Combined Therapy of Propranolol and Gabapentin in Paroxysmal Sympathetic Hyperactivity in Traumatic Brain Injury at Emergency Intensive Care Unit
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- mortality rate of patients
研究概览
简要总结
Paroxysmal sympathetic hyperactivity (PSH) is a syndrome that comprises a series of signs and symptoms reflecting exacerbated sympathetic activity, including arterial hypertension, fever, tachycardia, generalized perspiration, anomalous motor activity (dystonia, muscle stiffness, extension), tachypnea, mechanical ventilator maladjustment, hypoxemia, hypercapnia, and hyperglycemia. PSH episodes can be intense and prolonged and can occur several times a day and all of these can lead to secondary brain damage and are the main causes of a poor prognosis. Paroxysmal sympathetic hyperactivity also induces a hypermetabolic state with hypercatabolism and inflammation and increases vulnerability to infections, sepsis, and weight loss which in turn are associated with increased morbidity, longer hospital stay, and slower recovery. The marked and sustained increase in catecholamine levels predisposes to the development of cardiomyopathy, lung edema, arrhythmias, and cardiac and multisystemic dysfunction.
The reported incidence of paroxysmal sympathetic hyperactivity ranges from 8% to 33% and has no particular age or gender predilection. 80% of these syndrome incidents developed with traumatic brain injury.
详细描述
Traumatic brain injury (TBI) is a critical public health problem worldwide. It has been referred to as the " silent epidemic " as the problems experienced by those patients (such as impairments in memory or cognition) are often not visible.
According to the World Health Organization, traumatic brain injury will surpass many diseases as the major cause of death and disability. Each year an estimated 69 million individuals will suffer a TBI, the vast majority of which will be mild (81%) and moderate (11%) in severity. Many survivors live with significant disabilities, resulting in a major socioeconomic burden.
Nearly 60% of traumatic brain injuries are due to road traffic injuries in all parts of the world, about 20-30% are due to falls, 10% due to violence, and another 10% due to a combination of workplace and sports-related injuries.
Paroxysmal sympathetic hyperactivity (PSH) is a syndrome that comprises a series of signs and symptoms reflecting exacerbated sympathetic activity, including arterial hypertension, fever, tachycardia, generalized perspiration, anomalous motor activity (dystonia , muscle stiffness, extension), tachypnea, mechanical ventilator maladjustment, hypoxemia, hypercapnia, and hyperglycemia (Hughes and Rabinstein,2014). PSH episodes can be intense and prolonged and can occur several times a day and all of these can lead to secondary brain damage and are the main causes of a poor prognosis. Paroxysmal sympathetic hyperactivity also induces a hypermetabolic state with hypercatabolism and inflammation and increases vulnerability to infections, sepsis, and weight loss which in turn are associated with increased morbidity, longer hospital stay, and slower recovery. The marked and sustained increase in catecholamine levels predisposes to the development of cardiomyopathy, lung edema, arrhythmias, and cardiac and multisystemic dysfunction.
The reported incidence of paroxysmal sympathetic hyperactivity ranges from 8% to 33% and has no particular age or gender predilection. 80% of these syndrome incidents developed with traumatic brain injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• ICU patients with moderate (GCS 9-12) to severe (GCS <9) traumatic brain injury .
排除标准
- •Pre-existing brain dysfunction .
- •History of allergy to any of the combined drug therapy ( propranolol or gabapentine ) .
- •History of obstructive lung disease .
- •History of heart disease .
- •Hypotension at admission of ICU.
- •Bradycardia .
- •Hypertension
研究组 & 干预措施
propranolol group
addding propranolol to the traumatic brain injury protocol in Emergency ICU
干预措施: Propranolol , gabapentin (Drug)
combined propranolol and gabapentin
adding propranolol and gabapentin to the traumatic brain injury protocol in Emergency ICU
干预措施: Propranolol , gabapentin (Drug)
结局指标
主要结局
mortality rate of patients
时间窗: 8 months
to record the mortality rate of each group of patients
次要结局
- incidence of PSH(8 months)
- ICU length of stay(8 months)
- conscious level(8 months)
研究者
Essamedin Mamdouh Negm
principal investigator
Zagazig University
