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Cerebral Oxygen Challenge of Passive Leg Raising Test in Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523169
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief 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.

Condition or disease
Critical Illness Sepsis Cerebral Injury

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: The Correlation of Regional Cerebral Oxygen Saturation(rScO2) Variation in Passive Leg Raising (PLR) With Neurological Outcomes of Sepsis and Septic Shock Patients
Actual Study Start Date : December 31, 2016
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis




Primary Outcome Measures :
  1. Deilirium [ Time Frame: 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.


Secondary Outcome Measures :
  1. 28-day survival [ Time Frame: 28 days ]
    28-day survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The baseline parameters of sepsis and septic shock patients are collected
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523169


Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Director: Xiaoting Wang, MD Peking Unioin Medical College Hospital Critical Care Medicine Department
Additional Information:

Publications of Results:

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03523169    
Other Study ID Numbers: ZS-1475
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
Septic associated encephalopathy
Cerebral oxygenation
Prognosis
Passive leg raising
Additional relevant MeSH terms:
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Sepsis
Toxemia
Critical Illness
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes