NCT03173196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

May 30, 2017

Last Update Submit

August 10, 2017

Conditions

EncephalopathyOrgan Dysfunction Syndrome

Keywords

severe sepsisencephalopathy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • ICDSC Score

    Day 1

  • ICDSC Score

    Day 3

  • SOFA Score

    Day 1

  • SOFA Score

    Day 3

Study Arms (2)

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

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

Interventions

Non-invasive Multispectral SonographyDEVICE

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

Non-septic groupSepsis group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Units PIT 1+2, University Hospital Rostock

Rostock, 18055, Germany

Location

Related Publications (1)

  • 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.

    PMID: 36203789DERIVED

MeSH Terms

Conditions

Brain DiseasesSepsis

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy of the perioperative intensive care units

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 1, 2017

Study Start

June 1, 2016

Primary Completion

July 10, 2017

Study Completion

July 30, 2017

Last Updated

August 14, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)