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

Encephalopathy Clinical Trial

— SAEACG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03173196
• Other study ID #: A 2016-0026
• Status: Completed
• Phase: N/A
• First received: May 30, 2017
• Last updated: August 10, 2017
• Start date: June 1, 2016
• Est. completion date: July 30, 2017

Study information

• Verified date: August 2017
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 30, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Diseases
• Encephalopathy
• Organ Dysfunction Syndrome

Intervention

Device:
• Non-invasive Multispectral Sonography
We measure both groups wirh the non-invasive multispectral sonography for 3 and for 30 minutes.

Locations

Country	Name	City	State
Germany	Intensive Care Units PIT 1+2, University Hospital Rostock	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Principal Components analysis vs ICDSC (Intensive Care Delirium Screening Checklist)-Score	after genetic algorithm to find two components	Day 1
Primary	Principal Components analysis vs ICDSC / SOFA (Sepsis-related Organ Failure Assessment Score)-Score	after genetic algorithm to find two components	Day 1
Secondary	ICDSC Score	Delirium Score: Intensive Care Delirium Screening Checklist	Day 1
Secondary	ICDSC Score	Delirium Score: Intensive Care Delirium Screening Checklist	Day 3
Secondary	SOFA Score	Organ Function Score: Sepsis-related Organ Failure Assessment Score	Day 1
Secondary	SOFA Score	Organ Function Score: Sepsis-related Organ Failure Assessment Score	Day 3