EncephalopathySAEACGNCT03173196
Prospective Analysis of Septic Associated Encephalopathy Using the Non-invasive Acoustocerebrography-ACG
An observational study of Encephalopathy and Organ Dysfunction Syndrome, run by University of Rostock at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Encephalopathy, Organ Dysfunction Syndrome
- What is being tested?
- Non-invasive Multispectral Sonography
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2016to 30 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Intensive Care Units PIT 1+2, University Hospital Rostock
Rostock, 18055
About this study
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
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.
Read the 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.
- Conditions
- Encephalopathy, Organ Dysfunction Syndrome
- Being tested
- Non-invasive Multispectral Sonography
- Keywords
- severe sepsis, encephalopathy
- Medical subject headings
- Brain Diseases, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Multispectral SonographyDevice
We measure both groups wirh the non-invasive multispectral sonography for 3 and for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Non-invasive Multispectral Sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Principal Components analysis vs ICDSC (Intensive Care Delirium Screening Checklist)-Score
after genetic algorithm to find two components
Measured: Day 1
Principal Components analysis vs ICDSC / SOFA (Sepsis-related Organ Failure Assessment Score)-Score
after genetic algorithm to find two components
Measured: Day 1
Secondary outcomes (4)
ICDSC Score
Delirium Score: Intensive Care Delirium Screening Checklist
Measured: Day 1
ICDSC Score
Delirium Score: Intensive Care Delirium Screening Checklist
Measured: Day 3
SOFA Score
Organ Function Score: Sepsis-related Organ Failure Assessment Score
Measured: Day 1
SOFA Score
Organ Function Score: Sepsis-related Organ Failure Assessment Score
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 Jun 2016
- Primary completion10 Jul 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Martin Sauer, MD, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173196
- Sponsor's protocol ID
- A 2016-0026
- Acronym
- SAEACG
- Status last verified
- Aug 2017
- First submitted
- 30 May 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36203789
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03173196
- Acronym / sponsor ID
- SAEACG / A 2016-0026
- Conditions
- Encephalopathy, Organ Dysfunction Syndrome
- Keywords
- severe sepsis, encephalopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis group | – | Device: Non-invasive Multispectral SonographyPatients 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 | – | Device: Non-invasive Multispectral SonographyPatients without sepsis (surgical and non-surgical patients), staying at least 24 hours on an Intensive Care Unit, Non-invasive Multispectral Sonography - measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive Multispectral SonographyWe measure both groups wirh the non-invasive multispectral sonography for 3 and for 30 minutes. | Device | Non-septic group, Sepsis group |
Primary outcome
Principal Components analysis vs ICDSC (Intensive Care Delirium Screening Checklist)-Score
Time frame: Day 1
after genetic algorithm to find two components
Principal Components analysis vs ICDSC / SOFA (Sepsis-related Organ Failure Assessment Score)-Score
Time frame: Day 1
after genetic algorithm to find two components
4 secondary outcomes
ICDSC Score
Time frame: Day 1
ICDSC Score
Time frame: Day 3
SOFA Score
Time frame: Day 1
SOFA Score
Time frame: Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Derived from this study: PubMed 36203789Sauer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalopathy and Organ Dysfunction Syndrome, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Principal Components analysis vs ICDSC (Intensive Care Delirium Screening Checklist)-Score (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03173196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.