Cerebral Oxygen Challenge of Passive Leg Raising Test in Sepsis
Condition: Critical Illness; Sepsis; Cerebral Injury
MeSH terms: Sepsis; Toxemia; Brain Injuries; Critical Illness
Study type: Observational [Patient Registry]

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The baseline parameters of sepsis and septic shock patients are collected
      
Keywords: Septic associated encephalopathy; Cerebral oxygenation; Prognosis; Passive leg raising