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The objectives of this registry study are to:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in SOFA score D0 to SOFA Score D7 (or after last ARTICE® treatment, if later as D7). | SOFA Score is the Sequential Organ Failure Score providing information about mortality risk, 6 organs or organ systems are assesed using specific parameters, both the sum of the points and the point development of the individual organs can be considered, normal function of organ/organ system has 0 points, severely impacted function do have 4 point, in total you can have 0 points (every organ/organ system is normale) as a minimum and 24 points as maximum (severely impacted organ/organ system) | From enrollment up to 7 days after last ARTICE® treatment. |
| Changes in general SOFA score and SOFA sub scores. | SOFA Score is the Sequential Organ Failure Score providing information about mortality risk, 6 organs or organ systems are assesed using specific parameters, both the sum of the points and the point development of the individual organs can be considered, normal function of organ/organ system has 0 points, severely impacted function do have 4 point, in total you can have 0 points (every organ/organ system is normale) as a minimum and 24 points as maximum (severely impacted organ/organ system) | From enrollment up to 7 days after last ARTICE® treatment. |
| Changes in standard lab and inflammatory biomarkers. | standard lab and inflammatory biomarkers for exampample are: ferritine, total bilirubin, kreatinine, CRP, lactate, gammaglobuline, amount of the different blodd cell types, like neutrophils, lymphocytes | From enrollment up to 7 days after last ARTICE® treatment. |
| Hospital survival rates. | From enrollment up to 7 days after last ARTICE® treatment. | |
| Apache II Score. | APACHE II is a clinical rating system for evaluating the severity of an illness and the risk of death in intensive care medicine; score includes information on the patient's current condition, age and concomitant diseases, values are collected over 24 hours, highest value is included in calcutaion; the score can be at minimum 0 points (lightly risk of death) and at maximum 71 (very high risk of death) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens Altrichter, Dr. med. | Contact | +49 381 440 703 0 | jens.altrichter@artcline.de | |
| Judith Gross, M. Sc. | Contact | +49 1772216033 | judith.gross@artcline.de |
| Name | Affiliation | Role |
|---|---|---|
| Martin Sauer, Prof. Dr. med. | Klinikum Magdeburg, Klinik für Intensiv- & Rettungsmedizin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin | Recruiting | Magdeburg | 39130 | Germany |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| From enrollment up to 7 days after last ARTICE® treatment. |
| Length of ICU stay (days). | From enrollment up to 7 days after last ARTICE® treatment. |
| Mechanical ventilation days. | From enrollment up to 7 days after last ARTICE® treatment. |
| Renal replacement therapy days. | From enrollment up to 7 days after last ARTICE® treatment. |
| Vasopressor therapy days. | From enrollment up to 7 days after last ARTICE® treatment. |
| Frequency of secondary infections. | From enrollment up to 7 days after last ARTICE® treatment. |
| Type of secondary infections: it will be divided into viral, bacterial or fungi infection. | It is recorded whether the infection is viral, bacterial, or caused by fungi. And in case of bacterial infection it will be recorded weather, it is gram-positive or gram-negative bacterial infection. | From enrollment up to 7 days after last ARTICE® treatment. |
| Changes in the physiological parameter heartrate. | as physiological parameter will be measured heartrate in bpm | From enrollment up to 7 days after last ARTICE® treatment. |
| Changes in physiological parameter blood pressure. | as physiological parameter will be measured systolic and diastolic blood pressure in mmHg. | From enrollment up to 7 days after last ARTICE® treatment. |
| Changes in physiological parameter body temperature. | as physiological parameter will be measured body temperature in °C | From enrollment up to 7 days after last ARTICE® treatment. |
| Changes in physiological parameter mean arterial pressure. | as physiological parameter will be measured mean arterial pressure in mmHG | From enrollment up to 7 days after last ARTICE® treatment. |
| Complications related to the ARTICE® therapy application. | From enrollment up to 7 days after last ARTICE® treatment. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |