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

Completed

• Conditions: Encephalopathy; Organ Dysfunction Syndrome
• Interventions: Device: Non-invasive Multispectral Sonography

• Registration Number: NCT03173196
• Lead Sponsor: University of Rostock

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.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-06-01
• Primary Completion: 2017-07-10
• Study Completion: 2017-07-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis group	Non-invasive Multispectral Sonography	Patients with a septic shock or a severe sepsis (surgical and non-surgical patients), staying on Intensive Care Unit, Non-invasive Multispectral Sonography - measurement
Non-septic group	Non-invasive Multispectral Sonography	Patients without sepsis (surgical and non-surgical patients), staying at least 24 hours on an Intensive Care Unit, Non-invasive Multispectral Sonography - measurement

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ICDSC Score	Day 3	Delirium Score: Intensive Care Delirium Screening Checklist
SOFA Score	Day 3	Organ Function Score: Sepsis-related Organ Failure Assessment Score

Trial Locations

Locations (1)

Intensive Care Units PIT 1+2, University Hospital Rostock; 🇩🇪 Rostock, Germany