Ischemia Modified Albumin as a Biomarker for Prediction of Poor Outcome in Patients With Traumatic Brain Injury. Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Correlation between IMA and mortality following TBI
研究概览
简要总结
In the current study the investigators intend to evaluate the role of Ischemia modified albumin (IMA) in the prediction of poor outcome in patients with traumatic brain injury (TBI). The investigators hypothesize that IMA will be elevated in patients with traumatic brain injury due to the excessive production of reactive oxygen species by the injured brain.
详细描述
Consecutive adult patients who were admitted with TBI, blood samples were taken once written informed consent obtained. Initial evaluation on admission was performed simultaneously by ICU physician and a neurosurgical resident by means of a detailed physical and neurological examination. Demographic characteristics and vascular risk factors (hypertension, diabetes mellitus, hyperlipidemia, and peripheral ischemic disease) were recorded in details. Also, Routine blood tests, including full blood count, coagulation tests, glucose level, renal and hepatic function tests, total protein, and albumin levels; chest radiography were done.
CT scan will be performed in all the cases for the confirmation of TBI. Glasgow coma scale (GCS) was assessed on admission and recorded and assessed daily to evaluate prognosis. Patients were monitored by BP, ECG, and Pulse oximetry. All patients received standard medical treatment which included anti-edema measures mannitol 20%, 0.25-0.5 g/kg over 20 min, (not exceeding a total of 2 g/kg of body weight in 24 h) in patients with symptoms of raised intracranial pressure, and other supportive therapy for the treatment of concurrent illnesses such as hypertension and diabetes mellitus.
Biochemical Assessments:
Blood samples from TBI patients were collected immediately at the time of admission to the ICU and 24 hours later. Samples were centrifuged at 2500 RPM for 15 minutes and obtained serum samples were stored at -20oC.
IMA was measured by the colorimetric method and results were presented in absorbance units (ABSU).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age more than 18 years old
- •Patients with isolated head injury
排除标准
- •Age < 18 years old
- •Pregnant patient
- •Acute hepatitis or severe liver disease (Child-Pugh class C)
- •Patients with recent pulmonary embolism
- •Patients with unstable angina or recent myocardial infarction (MI)
- •Peripheral arterial disease
- •Acute stroke
- •Chronic renal failure (CRF)
- •Hypoalbuminemia less than 3.5
- •Patients with other organs injury
- •Penetrating head injury
- •Head trauma more than 24 hours before admission
- •Patients with known inflammatory or autoimmune diseases
结局指标
主要结局
Correlation between IMA and mortality following TBI
时间窗: The number of patients who died within 28 days from admission to ICU after TBI and who were investigated for IMA upon admission to ICU
IMA in ng/ml will be measured at time of admission to ICU and correlated with 28 day mortality
次要结局
- Correlation between 24 hours IMA and mortality following TBI(The number of patients who died within 28 days from admission to ICU after TBI and who were investigated for IMA 24 hours after admission to ICU)
- The degree of correlation between severity of TBI and IMA(Glasgow coma scale immediately on admission to the ICU, IMA will be collected on admission to ICU and after 24 hours)
- The incidence of patients with elevated IMA(IMA on admission to ICU and after 24 hours)
- The degree of correlation between severity of TBI and and deterioration of conscious level(Glasgow coma scale immediately on admission to the ICU and daily till mortality or discharge up to 28 days post admission)
- The degree of correlation between mild TBI and ICU length of stay(The number of days in ICU till discharge or mortality up to 28 days post admission)
- The degree of correlation between moderate TBI and ICU length of stay(The number of days in ICU till discharge or mortality up to 28 days post admission)
- The degree of correlation between severe TBI and ICU length of stay(The number of days in ICU till discharge or mortality up to 28 days post admission)
研究者
Rania Samir Fahmy
Lecturer of Anesthesia, surgical intensive care and pain mangement
Kasr El Aini Hospital