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临床试验/NCT05427474
NCT05427474招募中3 期

Role of Combined Therapy of Propranolol and Gabapentin in Paroxysmal Sympathetic Hyperactivity in Traumatic Brain Injury at Emergency Intensive Care Unit

Zagazig University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年12月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

addding propranolol to the traumatic brain injury protocol in Emergency ICU

干预措施: Propranolol , gabapentin (Drug)

combined propranolol and gabapentin

Active Comparator

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Essamedin Mamdouh Negm

principal investigator

Zagazig University

研究点 (2)

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