Prospective Analysis of Septic Associated Encephalopathy Using the Non-invasive Acoustocerebrography-ACG

Study Overview
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Brief Summary
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The patients of the group sepsis are measured several times with the non-invasive multi-spectral sonography (Sonovum ACG-Diagnosesystem) (days 1, 3, 7 and 14). The patients of the group control are measured on days 1 and 3 with the system. A measurement takes 3 minutes. For this purpose two ultrasound heads are placed above the patient's ears and fixed with an all-head harness. The device is certified for CE application. There are no known health risks of ultrasound in humans.

Detailed Description
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Sepsis with multiorgan failure is one of the most common diseases in intensive care units and is at the top of the world of causes of death. In addition to increasingly serious sepsis by multidrug-resistant pathogens, neurological symptoms are frequently recorded in the systemic manifestation of the disease pattern. Septic encephalopathy (SE) is usually an early cerebral sign of the developing sepsis, often before other clinically as well as diagnostically detectable findings such as fever ascent, hypotonia or laboratory chemical infections. Therefore, the SE is a clinically important parameter, also because after the sepsis, cerebral functional restrictions such as cognitive disorders can persist in the long term. Therefore, on day 1, 3, 7 and 14 the patients are measured with the ACG-system as well as determined different scores of the patients: CAM-ICU (Confusion Assessment Method - Intensive Care Unit) and ICDSC (Intensive Care Delirium Screening Checklist) for the neurological outcome; Apache (Acute Physiology And Chronic Health Evaluation) II for mortality and SOFA (Sepsis-related Organ Failure Assessment Score) for organ failure.

Official Title
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Prospective Analysis of the Occurrence and Severity of Septic Encephalopathy in Patients With Severe Sepsis or Septic Shock, Including Non-invasive Multispectral Sonography

Conditions
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Encephalopathy, Organ Dysfunction Syndrome

Intervention / Treatment
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* Device: Non-invasive Multispectral Sonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe sepsis or septic shock Clinical suspicion of septic encephalopathy consent to the study by the patient or legal representative stay in intensive care unit for at least 24 hours without the presence of a septic disease and without clinical guidance for an SE Exclusion Criteria: Inability to consent to participation in the research project or rejection by patients or legal representatives existence of other causes of delir other than sepsis (e.g., withdrawal) Infrequent prognosis (expected death in ≤ 12 hours despite maximum therapy)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sepsis group<br>Patients with a septic shock or a severe sepsis (surgical and non-surgical patients), staying on Intensive Care Unit, Non-invasive Multispectral Sonography - measurement | Device: Non-invasive Multispectral Sonography<br>* We measure both groups wirh the non-invasive multispectral sonography for 3 and for 30 minutes.<br>|
| Non-septic group<br>Patients without sepsis (surgical and non-surgical patients), staying at least 24 hours on an Intensive Care Unit, Non-invasive Multispectral Sonography - measurement | Device: Non-invasive Multispectral Sonography<br>* We measure both groups wirh the non-invasive multispectral sonography for 3 and for 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Principal Components analysis vs ICDSC (Intensive Care Delirium Screening Checklist)-Score | after genetic algorithm to find two components | Day 1 | 
| Principal Components analysis vs ICDSC / SOFA (Sepsis-related Organ Failure Assessment Score)-Score | after genetic algorithm to find two components | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICDSC Score | Delirium Score: Intensive Care Delirium Screening Checklist | Day 1 | 
| ICDSC Score | Delirium Score: Intensive Care Delirium Screening Checklist | Day 3 | 
| SOFA Score | Organ Function Score: Sepsis-related Organ Failure Assessment Score | Day 1 | 
| SOFA Score | Organ Function Score: Sepsis-related Organ Failure Assessment Score | Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe sepsis, encephalopathy