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

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

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.

Study Overview

• Status: Completed
• Conditions: Encephalopathy; Organ Dysfunction Syndrome
• Intervention / Treatment: Device: Non-invasive Multispectral Sonography

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Germany
  • Rostock, Germany, 18055
    • Intensive Care Units PIT 1+2, University hospital Rostock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• male or female, at least 18 years old
• Severe sepsis or septic shock
• Clinical suspicion of SE
• consent to the study by the patient or legal representative

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sepsis group; 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; We measure both groups wirh the non-invasive multispectral sonography for 3 and for 30 minutes.
Non-septic group; 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; We measure both groups wirh the non-invasive multispectral sonography for 3 and for 30 minutes.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Rostock

Publications and helpful links

General Publications

• Sauer M, Sievert A, Wrobel M, Schmude P, Richter G. Acoustocerebrography in septic patients: A randomized and controlled pilot study. Front Med Technol. 2022 Sep 14;4:920674. doi: 10.3389/fmedt.2022.920674. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): July 10, 2017
• Study Completion (Actual): July 30, 2017

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: severe sepsis; encephalopathy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Brain Diseases
• Other Study ID Numbers: A 2016-0026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No