ROS in TBI Patients in Relation to Level of Oxygenation. (ROS-TBI)
Formation of Reactive Oxygen Species in Patients With Severe Traumatic Brain Injury in Normal vs Increased Oxygenation.
This project an observational study performed on patients with severe Traumatic Brain Injury (TBI) treated at Neurosurgical ICU (NICU) at Karolinska University Hospital. The purpose of this study is to evaluate the effects of various oxygenation levels on production rate of Reactive Oxygen Species (ROS) in patients with severe traumatic brain injury (TBI). The patients will be included in the study after the placement of intracranial monitoring device consisting of intracranial pressure gage (Codman), microdialysis (MD), and Licox oxygen electrode for measurement of partial pressure of oxygen in brain tissue (pBtO2). Intracranial monitoring is inserted on clinical indications and is used for early detection of deleterious processes in brain tissue such as hypoxia or hypoperfusion and for purpose of guiding of given therapies such as cerebral perfusion pressure (CPP), oxygenation, dosage of vasoactive drugs etc. Despite the technical possibilities to monitor all these physiological parameters, there are no clear guidelines how to interpret the MD and pBtO2 data and implement it in clinical decision making. One of the controversies deals with optimization of oxygen levels: some authors point out the importance of adequate brain tissue oxygenation, whereas other researchers are worried about the possible negative effects of excessive oxygen levels such as increased production of ROS or facilitating pulmonary atelectasis, contributing to adverse outcome.
The purpose of this study is to investigate the effect of various oxygenation levels on ROS production in TBI patients.
This pilot study is designed to measure short-lived ROS in blood and microdialysis fluid samples of TBI patients during alternating periods of normal vs temporarily increased oxygenation levels under normobaric conditions (normal atmospheric pressure).
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Stockholm、瑞典、17176
- Karolinska University Hospital
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接触:
- Michael Nekludov, MD PhD
- 邮箱:michael.nekludov@regionstockholm.se
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Severe isolated TBI (GCS<8, AIS =<3), CT-verified TBI (tSDH,tEDH, tSAH, contusion bleedings) caused by blunt or penetrating trauma.
- Established intracranial monitoring (ICP, MD, LiCox pBtO2) at NICU.
- Age >= 18
- Time from trauma from 0 to 4 days.
- Informed consent from Close relative.
- Systemic hyperoxygenation can be used in patients with pBtO2 <20 mmHg, based on clinical decision.
Exclusion Criteria:
- Major extracranial injury, AIS >3
- Brain dead or expected survival <24 hours
- Pregnancy
- Respiratory insufficiency FiO2> 40%
6. No consent from relative.
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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ROS concentrations in blood
大体时间:7 days
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ROS concentrations in patient´s blood will be measured repeatedly at normal systemic oxygenation and at increased oxygenation if necessary.
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7 days
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Markers of oxidative stress
大体时间:7 days
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Indirect markers of oxydative stress, as MDA (Malondialdehyde) and Isoprostane F2, in relation to level of systemic oxygenation.
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7 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- K2020-1148
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