Brain Injuries, AcuteACG-BrainICUNCT03635736
Acustocerebrography (ACG) in Severe Brain Injury
An observational study of Brain Injuries, Acute, run by University of Rostock at 1 site in Germany.
Trial summary
The study will enable the clinical applicability of the multiple-spectral-sonography for detection of severe brain injury in ICU patients. For this, the ACG diagnostic system (Sonovum AG, Leipzig, Germany) should be used as additional diagnostic tool in prospective single-center study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Acute
- What is being tested?
- multiple-spectral-sonography as acustocerebrography (ACG)
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 14 Aug 2018to Oct 2021
- 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: - ICU-patients over 17 years old with suspected severe brain injury
Who may be able to join
- suspected severe brain injury
Who cannot join
- open skull brain trauma
- skull fractures in the temporal area
- decompression-craniotomy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Intensive Care Units PIT 1+2, University hospital Rostock
Rostock, 18055
Martin Sauer, PD Dr., 49 381 4946434
About this study
Official title: Study on Additive Use of Non-invasive Acustocerebrography in Patients Suspect to Severe Brain Injury
The study will enable the clinical applicability of the multiple-spectral-sonography for detection of severe brain injury in ICU patients. For this, the ACG diagnostic system (Sonovum AG, Leipzig, Germany) should be used as additional diagnostic tool in prospective single-center study.
Read the detailed description
A multiple-step procedure, including repetition of the clinical examinations after a waiting period and use of additional technical diagnostic tools e.g. magnetic resonance tomography and Transcranial Doppler sonography (TCD) are needed for determining of severe brain injury and irreversible brain function failure.
This study will enable the clinical applicability of the multiple-spectral-sonography for detection of severe brain injury in ICU patients. For this, the ACG diagnostic system (Sonovum AG, Leipzig, Germany) should be used as additional diagnostic tool in prospective single-center study.
The ACG-method is a bedside non-invasive sonography that has been shown to be useful in previous studies analyzing circulatory changes in rat cerebral blood vessels, for example, to distinguish between brain-ischemia and -hemorrhage. Additionally, in the case of brain death, the spontaneous electrical activity, which can be measured by means of ACG as global elasticity, was not longer detectable.
In the study should include 30 adult ICU-patients in patients suspect to severe brain injury. The inclusion of patients will be started if written informed consent was obtained from participants or their representatives. After the inclusion, the ACG is measured three times a day. In addition, the routinely practice (treatment and diagnostic) for patients with severe brain injury (neurological clinical examinations, use of additional technical diagnostic tools e.g. magnetic resonance tomography and Transcranial Doppler sonography (TCD); Standard Medical Care) should be made and documented. From all patients basic demographic data, pre-morbidity, vital parameters, blood parameters, Illness severity scores (APACHE-II, SOFA, GCS), drug levels, microbiological results and cranial MRI/CT results will be recorded.
- Conditions
- Brain Injuries, Acute
- Being tested
- multiple-spectral-sonography as acustocerebrography (ACG)
- Keywords
- brain damage, sonography
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple-spectral-sonography as acustocerebrography (ACG)Other
After inclusion three times at day measurements with ACG for each 45 minutes; a (non-invasive) sonography. The measurements will be stopped after final evaluation of the neurological status using common methods like magnetic resonance tomography, transcranial doppler sonography, electroencephalography and other methods.
| Study group | Role | What they receive |
|---|---|---|
| Severe brain injury | ICU-patients suspect to severe brain injury, measurement with multiple-spectral-sonography as acustocerebrography (ACG Receives: Other: multiple-spectral-sonography as acustocerebrography (ACG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
acustocerebrography (ACG)
changes in the ACG during the course of disease (especially the dimensionality of the time to flight of the ultrasound signal)
Measured: after inclusion: time-point 0 hours
Secondary outcomes (2)
SOFA
Evaluation of the SOFA-Score
Measured: every day, at least after 28 days
acustocerebrography (ACG)
changes in the ACG during the course of disease (especially the dimensionality of the time to flight of the ultrasound signal)
Measured: Every day to 3 time-points. The measurements will be stopped after final evaluation of the neurological status, at least after 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start14 Aug 2018
- Primary completionAug 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, AcuteStudies 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
- 30 participants (estimated)
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
- Investigators
- Martin Sauer, MD, Principal investigator, University Medical Center Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635736
- Sponsor's protocol ID
- A 2018-0062
- Acronym
- ACG-BrainICU
- Status last verified
- Apr 2020
- First submitted
- 25 Jul 2018
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Additive Use of Non-invasive Acustocerebrography in Patients Suspect to Severe Brain Injury
- ClinicalTrials.gov ID
- NCT03635736
- Acronym / sponsor ID
- ACG-BrainICU / A 2018-0062
- Conditions
- Brain Injuries, Acute
- Keywords
- brain damage, sonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 17 Aug 2018 (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 study will enable the clinical applicability of the multiple-spectral-sonography for detection of severe brain injury in ICU patients. For this, the ACG diagnostic system (Sonovum AG, Leipzig, Germany) should be used as additional diagnostic tool in prospective single-center study.
Detailed description
A multiple-step procedure, including repetition of the clinical examinations after a waiting period and use of additional technical diagnostic tools e.g. magnetic resonance tomography and Transcranial Doppler sonography (TCD) are needed for determining of severe brain injury and irreversible brain function failure.
This study will enable the clinical applicability of the multiple-spectral-sonography for detection of severe brain injury in ICU patients. For this, the ACG diagnostic system (Sonovum AG, Leipzig, Germany) should be used as additional diagnostic tool in prospective single-center study.
The ACG-method is a bedside non-invasive sonography that has been shown to be useful in previous studies analyzing circulatory changes in rat cerebral blood vessels, for example, to distinguish between brain-ischemia and -hemorrhage. Additionally, in the case of brain death, the spontaneous electrical activity, which can be measured by means of ACG as global elasticity, was not longer detectable.
In the study should include 30 adult ICU-patients in patients suspect to severe brain injury. The inclusion of patients will be started if written informed consent was obtained from participants or their representatives. After the inclusion, the ACG is measured three times a day. In addition, the routinely practice (treatment and diagnostic) for patients with severe brain injury (neurological clinical examinations, use of additional technical diagnostic tools e.g. magnetic resonance tomography and Transcranial Doppler sonography (TCD); Standard Medical Care) should be made and documented. From all patients basic demographic data, pre-morbidity, vital parameters, blood parameters, Illness severity scores (APACHE-II, SOFA, GCS), drug levels, microbiological results and cranial MRI/CT results will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe brain injury | – | Other: multiple-spectral-sonography as acustocerebrography (ACG)ICU-patients suspect to severe brain injury, measurement with multiple-spectral-sonography as acustocerebrography (ACG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - ICU-patients over 17 years old with suspected severe brain injury
Key inclusion criteria (1 listed)
- suspected severe brain injury
Key exclusion criteria (3 listed)
- open skull brain trauma
- skull fractures in the temporal area
- decompression-craniotomy
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 |
|---|---|---|
| multiple-spectral-sonography as acustocerebrography (ACG)After inclusion three times at day measurements with ACG for each 45 minutes; a (non-invasive) sonography. The measurements will be stopped after final evaluation of the neurological status using common methods like magnetic resonance tomography, transcranial doppler sonography, electroencephalography and other methods. | Other | Severe brain injury |
Primary outcome
acustocerebrography (ACG)
Time frame: after inclusion: time-point 0 hours
changes in the ACG during the course of disease (especially the dimensionality of the time to flight of the ultrasound signal)
2 secondary outcomes
SOFA
Time frame: every day, at least after 28 days
acustocerebrography (ACG)
Time frame: Every day to 3 time-points. The measurements will be stopped after final evaluation of the neurological status, at least after 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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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.
Martin Sauer, MD principal investigator
University Medical Center Rostock
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 Brain Injuries, Acute, 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 1 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: status not confirmed, as of the sponsor's last update on 7 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Sauer, MD (+493814946409, martin.sauer@uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acustocerebrography (ACG) (time frame: after inclusion: time-point 0 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2020.