ARTICE® Real Data Collection & Observational Trial, Phase 4 Study

Primary outcomes

1. Change in SOFA score D0 to SOFA Score D7 (or after last ARTICE® treatment, if later as D7).

   Time frame: From enrollment up to 7 days after last ARTICE® treatment.

   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)

2. Changes in general SOFA score and SOFA sub scores.

   Time frame: From enrollment up to 7 days after last ARTICE® treatment.

   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)

3. Changes in standard lab and inflammatory biomarkers.

   Time frame: From enrollment up to 7 days after last ARTICE® treatment.

   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

4. Hospital survival rates.

   Time frame: From enrollment up to 7 days after last ARTICE® treatment.

5. Apache II Score.

   Time frame: From enrollment up to 7 days after last ARTICE® treatment.

   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)

6. Length of ICU stay (days).

   Time frame: From enrollment up to 7 days after last ARTICE® treatment.

7. Mechanical ventilation days.

   Time frame: From enrollment up to 7 days after last ARTICE® treatment.

8. Renal replacement therapy days.

   Time frame: From enrollment up to 7 days after last ARTICE® treatment.

9. Vasopressor therapy days.

   Time frame: From enrollment up to 7 days after last ARTICE® treatment.

10. Frequency of secondary infections.

    Time frame: From enrollment up to 7 days after last ARTICE® treatment.

11. Type of secondary infections: it will be divided into viral, bacterial or fungi infection.

    Time frame: From enrollment up to 7 days after last ARTICE® treatment.

    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.

12. Changes in the physiological parameter heartrate.

    Time frame: From enrollment up to 7 days after last ARTICE® treatment.

    as physiological parameter will be measured heartrate in bpm

13. Changes in physiological parameter blood pressure.

    Time frame: From enrollment up to 7 days after last ARTICE® treatment.

    as physiological parameter will be measured systolic and diastolic blood pressure in mmHg.

14. Changes in physiological parameter body temperature.

    Time frame: From enrollment up to 7 days after last ARTICE® treatment.

    as physiological parameter will be measured body temperature in °C

15. Changes in physiological parameter mean arterial pressure.

    Time frame: From enrollment up to 7 days after last ARTICE® treatment.

    as physiological parameter will be measured mean arterial pressure in mmHG

16. Complications related to the ARTICE® therapy application.

    Time frame: From enrollment up to 7 days after last ARTICE® treatment.