Skip to main content
OpenTrials
Completed

NCT Number: NCT03173196

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive Care Units PIT 1+2, University Hospital Rostock

Rostock, 18055, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Non-invasive Multispectral Sonography

Device

We measure both groups wirh the non-invasive multispectral sonography for 3 and for 30 minutes.

Primary outcomes

  1. Principal Components analysis vs ICDSC (Intensive Care Delirium Screening Checklist)-Score

    Time frame: Day 1

    after genetic algorithm to find two components

  2. Principal Components analysis vs ICDSC / SOFA (Sepsis-related Organ Failure Assessment Score)-Score

    Time frame: Day 1

    after genetic algorithm to find two components

Secondary outcomes

  1. ICDSC Score

    Time frame: Day 1

    Delirium Score: Intensive Care Delirium Screening Checklist

  2. ICDSC Score

    Time frame: Day 3

    Delirium Score: Intensive Care Delirium Screening Checklist

  3. SOFA Score

    Time frame: Day 1

    Organ Function Score: Sepsis-related Organ Failure Assessment Score

  4. SOFA Score

    Time frame: Day 3

    Organ Function Score: Sepsis-related Organ Failure Assessment Score

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Official study title

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

Acronym: SAEACG

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 1, 2017
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.