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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive Multispectral Sonography | Device | We measure both groups wirh the non-invasive multispectral sonography for 3 and for 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ICDSC Score | Delirium Score: Intensive Care Delirium Screening Checklist | Day 1 |
| ICDSC Score | Delirium Score: Intensive Care Delirium Screening Checklist |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Care Units PIT 1+2, University Hospital Rostock | Rostock | 18055 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36203789 | Derived | 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. |
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| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
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| Day 3 |
| SOFA Score | Organ Function Score: Sepsis-related Organ Failure Assessment Score | Day 1 |
| SOFA Score | Organ Function Score: Sepsis-related Organ Failure Assessment Score | Day 3 |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |