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

• Sponsor: University of Rostock (Other)
• Overall Status: Completed
• CT.gov ID: NCT03173196
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 13.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Encephalopathy; Organ Dysfunction Syndrome	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 Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jul 10, 2017
• Actual Study Completion Date: Jul 30, 2017

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

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

   after genetic algorithm to find two components

2. 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

1. ICDSC Score [Day 1]

   Delirium Score: Intensive Care Delirium Screening Checklist

2. ICDSC Score [Day 3]

   Delirium Score: Intensive Care Delirium Screening Checklist

3. SOFA Score [Day 1]

   Organ Function Score: Sepsis-related Organ Failure Assessment Score

4. SOFA Score [Day 3]

   Organ Function Score: Sepsis-related Organ Failure Assessment Score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intensive Care Units PIT 1+2, University Hospital Rostock	Rostock		Germany	18055

Sponsors and Collaborators

• University of Rostock

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Martin Sauer, MD, Deputy of the perioperative intensive care units, University of Rostock
• ClinicalTrials.gov Identifier: NCT03173196
• Other Study ID Numbers: A 2016-0026
• First Posted: Jun 1, 2017
• Last Update Posted: Aug 14, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Dr. Martin Sauer, MD, Deputy of the perioperative intensive care units, University of Rostock: severe sepsis; encephalopathy
• Additional relevant MeSH terms: Brain Diseases

Study Results

No Results Posted as of Aug 14, 2017