A Clinical Trial of the Effect of Midazolam on the Cerebral Metabolism and Inflammatory Response in Patients With Moderate and Severe Traumatic Brain Injury
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cerebral metabolic parameters
研究概览
简要总结
To explore the cerebral protective effect of midazolam in patients with traumatic brain injury, we will collect blood samples from patients treated with or without midazolam when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission before the use of midazolam for patients in group N1, and before the patient is treated with midazolam, 24 h， 48 h, 72 h after the use of midazolam for patients in group N2. Parameters of cerebral metabolism and inflammatory response will be obtained from the blood samples or the cerebrospinal fluid. With the aforementioned parameters, the relationship between clinical outcome and cerebral metabolism and inflammatory response will be detected with statistical method.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or older;
- •Hospitalized in ICU within 6 hours after the injury or after the operation;
- •Traumatic brain injury is confirmed by computed tomography scan or magnetic resonance imaging, Glasgow Coma Scale is 3 to 12, and the patient should meet the diagnostic standard of severe traumatic brain injury;
- •Informed consent is obtained.
排除标准
- •Aged less than 18;
- •Death is expected in 24 hours;
- •History of neurological disease or history of drug abuse which may affect the outcome of the study;
- •Failed to obtain Informed consent.
研究组 & 干预措施
N1(traditional treatment group)
Patients in group N1 are treated with basic therapeutic measures which include reducing intracranial pressure with mannitol, hemostasis, acid inhibition, anti-infection, nutrition support and control of blood glucose, blood pressure and body temprature.
干预措施: Placebo (Drug)
N2(midazolam group)
Patients in group N2 was treated with intravenous infusion of midazolam on the basis of basic treatment measures which include reducing intracranial pressure with mannitol, hemostasis, acid inhibition, anti-infection, nutrition support and control of blood glucose, blood pressure and body temprature.
干预措施: Midazolam (Drug)
结局指标
主要结局
Cerebral metabolic parameters
时间窗: from the admission to ICU to 72 h after the admission for Group N1 and before the use of midazolam to 72 h after the use for group N2
N1 group: blood samples will be collected when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission N2 group: blood samples will be collected before the use of midazolam, 24 h, 48 h and 72 h after the use Blood sample will be collected every time from the radial artery and the jugular bulb separately. The blood sample will be used for blood gas analysis Detail parameters by blood test: levels of lactic acid, oxygen saturation(SaO2), partial pressure of oxygen(Pa02), jugular bulb venous oxygen saturation(SjvO2), jugular bulb oxygen partial pressure(PjvO2), hemoglobin(Hb) Calculated parameters: arterial oxygen content(Ca02), jugular venous oxygen saturation (SjvO2), arterial venous oxygen content difference(Da-jvO2), cerebral extraction of oxygen(CERO2), Lactate differences between jugular and arterial blood(AVDL) and Cerebral lactate acid production(CLP)
Parameters of intracranial inflammatory response
时间窗: from the admission to ICU to 72 h after the admission for Group N1 and before the use of midazolam to 72 h after the use for group N2
N1: blood samples and cerebrospinal fluid are collected when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission N2: blood samples and cerebrospinal fluid are collected before the use of midazolam, 24 h, 48 h and 72 h after the use every time, 3 ml blood sample will be collected from the jugular bulb and 2 ml cerebrospinal fluid will be collected at the corresponding time The blood sample will be anticoagulated by EDTA and then it will be centrifuged at 3000 r/min for 10 minutes within 30 minutes from the collection. The supernatant liquid will be stored in the freezer at -70℃. The cerebrospinal fluid centrifuged at 3000 r/min for 10 minutes, and then the supernatant liquid will be stored in the freezer at -80℃. Detail parameters: sFkn and IL-6 levels of the blood sample and CSF will be tested 2 times by ELISA and then take the average.
次要结局
- Ramsay score(from the use of midazolam to 72 h after the use for group N2)
- seizure(from the admission to ICU to 72 h after the admission)
- one-week mortality(from the admission to ICU to one week after the admission)