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Cerebral Oxygen Challenge of Passive Leg Raising Test in Sepsis

2018年5月11日 更新者:Peking Union Medical College Hospital

The Correlation of Regional Cerebral Oxygen Saturation(rScO2) Variation in Passive Leg Raising (PLR) With Neurological Outcomes of Sepsis and Septic Shock Patients

Sepsis related cerebral dysfunction was underestimated in critical illness setting, and inflammatory response of brain could not be monitored directly and cerebral oximetry offered information of cerebral dysfunction. We had hypothesized cerebral oxygenation responsiveness during passive leg raising could in some way had association in predicting with the outcomes of septic shock.

研究概览

地位

完全的

详细说明

Research question: Does increased regional cerebral oxygen saturation variation in passive leg raising(PLR) associated with better neurological outcomes of sepsis and septic shock patients?

Specific aims:

  1. To stablish an algorithm to assess focal neurological dysfunction through regional cerebral oxygen saturation(rScO2) of sepsis and septic shock patients
  2. To assess the safety and gain some experiences evaluate cerebral oxygen in passive leg raising and fluid expansion.
  3. To test the correlation of rScO2 variation with neurological complication and prognosis of septic shock patients.

Significance:

  1. Sepsis and septic shock were associated with increased risk of mortality, elevated morbidity rates, and neuro-developmental disability.
  2. The definition of SEPSIS 3.0, signify qSOFA scores as a bedside prompt that may identify patients with suspected infection who are at greater risk for a poor outcome, It uses three criteria, including altered mentation (Glasgow coma scale<15).
  3. Previously, sepsis related cerebral dysfunction was underestimated in critical illness setting, and inflammatory response of brain, such as oxygen deficit of brain tissue could not be monitored directly, thus cerebral oximetry monitoring could be used for the evaluation of cerebral tissue oxygenation in real time, providing indirect information of the brain function during sepsis and septic shock.
  4. Length of reduced cerebral oxygen saturation was confirmed associated with worse outcome after major surgery perioperatively. We hypothesized that cerebral oxygen metabolism was degenerated during sepsis and septic shock, and lower cerebral oxygenation would have somewhat correlations with worse outcome of sepsis and septic shock patients.

Study Design: This will be a observational cohort trial. The schematic diagram of the study is as Figure 1. Subjects will be enrolled, and then be followed up. The outcome variables will be recorded. Inclusion criteria were age above 18 either under 80 years, and diagnosed with sepsis, using Sepsis 3.0 criteria.

Whereas exclusion criteria were patients who were under 18 or above 80 years, pregnant, brain dead, severe head trauma, patients who had a difference more than 10% between the 2 probes of cerebral oxygen saturation monitor due to possible unilateral focal pathology, and whose cousins made decision to withdraw from resuscitation.

The baseline parameters of sepsis and septic shock patients are collected: demographic data (age, sex, comorbidities, resources and diagnosis), Acute Physiology and Chronic Health Evaluation (APACHE) II score (on admission and after 24 hours), hemo-dynamic parameters (mean arterial pressure [MAP], heart rate, cardiac index [CI], stroke volume variation, and global end-diastolic index using PICCO Monitor from Pulsion, Germany), serial lactic acid measurements at presentation and after 48 hours, blood gases (arterial and central venous [at presentation and every 8 hours]), and rScO2 (at presentation and every 8 hours). Delirium were diagnosed using CAM-ICU criteria for delirium in ICU.

研究类型

观察性的

注册 (实际的)

120

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

The baseline parameters of sepsis and septic shock patients are collected

描述

Inclusion Criteria:

  • Age above 18 either under 80 years, and diagnosed with sepsis, using Sepsis 3.0 criteria.

Exclusion Criteria:

  • Patients who were under 18 or above 80 years, pregnant, brain dead, severe head trauma, patients who had a difference more than 10% between the 2 probes of cerebral oxygen saturation monitor due to possible unilateral focal pathology, and whose cousins made decision to withdraw from resuscitation.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
Deilirium
大体时间:7 days
Delirium, also known as acute confusional state, is an organically caused decline from a previously baseline level of mental function.It typically involves other cognitive deficits, changes in arousal (hyperactive, hypoactive, or mixed), perceptual deficits, altered sleep-wake cycle, and psychotic features such as hallucinations and delusions. Our every patient gets checked for delirium every day (usually twice or more a day) using a validated clinical tool of Confusion Assessment Method for the ICU (CAM-ICU).The first step to assessing consciousness is to assess level of consciousness.The next step is assessment of content of consciousness. Think: rapid onset, inattention, clouded consciousness (bewildered), fluctuating.
7 days

次要结果测量

结果测量
措施说明
大体时间
28 天生存期
大体时间:28天
28 天生存期
28天

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Xiaoting Wang, MD、Peking Unioin Medical College Hospital Critical Care Medicine Department

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年12月31日

初级完成 (实际的)

2017年11月1日

研究完成 (实际的)

2017年12月31日

研究注册日期

首次提交

2018年4月11日

首先提交符合 QC 标准的

2018年5月11日

首次发布 (实际的)

2018年5月14日

研究记录更新

最后更新发布 (实际的)

2018年5月14日

上次提交的符合 QC 标准的更新

2018年5月11日

最后验证

2018年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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