CompletedNot Applicable

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

Germany20 participantsStarted 2016-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Principal Components analysis vs ICDSC (Intensive Care Delirium Screening Checklist)-Score

Timeframe: Day 1

Principal Components analysis vs ICDSC / SOFA (Sepsis-related Organ Failure Assessment Score)-Score

Timeframe: Day 1

Trial details

NCT IDNCT03173196

SponsorUniversity of Rostock

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-07-10

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