Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03173196
Acronym
SAEACG
Enrollment
20
Registered
2017-06-01
Start date
2016-06-01
Completion date
2017-07-30
Last updated
2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalopathy, Organ Dysfunction Syndrome

Keywords

severe sepsis, encephalopathy

Brief summary

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

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.

Interventions

DEVICENon-invasive Multispectral Sonography

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

Sponsors

University of Rostock
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Principal Components analysis vs ICDSC (Intensive Care Delirium Screening Checklist)-ScoreDay 1after genetic algorithm to find two components
Principal Components analysis vs ICDSC / SOFA (Sepsis-related Organ Failure Assessment Score)-ScoreDay 1after genetic algorithm to find two components

Secondary

MeasureTime frameDescription
ICDSC ScoreDay 1Delirium Score: Intensive Care Delirium Screening Checklist
SOFA ScoreDay 1Organ Function Score: Sepsis-related Organ Failure Assessment Score

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026