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

Condition(s) studied

Study summary

The objectives of this registry study are to:

1. Record real-life data related to the use of the ARTICE® therapy in sepsis subjects.
2. Further evaluate ARTICE® treatment efficacy.
3. Identify potential sub-groups, assess their risk-benefit- and safety profile.
4. Changes in SOFA score D0 to SOFA Score D7.

Eligibility

Primary outcome measure(s)

• Change in SOFA score D0 to SOFA Score D7 (or after last ARTICE® treatment, if later as D7). — 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)
• Changes in general SOFA score and SOFA sub scores. — 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)
• Changes in standard lab and inflammatory biomarkers. — 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
• Hospital survival rates. — From enrollment up to 7 days after last ARTICE® treatment.
• Apache II Score. — 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)
• 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. — 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.
• Changes in the physiological parameter heartrate. — From enrollment up to 7 days after last ARTICE® treatment.
  as physiological parameter will be measured heartrate in bpm
• Changes in physiological parameter blood pressure. — From enrollment up to 7 days after last ARTICE® treatment.
  as physiological parameter will be measured systolic and diastolic blood pressure in mmHg.
• Changes in physiological parameter body temperature. — From enrollment up to 7 days after last ARTICE® treatment.
  as physiological parameter will be measured body temperature in °C
• Changes in physiological parameter mean arterial pressure. — From enrollment up to 7 days after last ARTICE® treatment.
  as physiological parameter will be measured mean arterial pressure in mmHG
• Complications related to the ARTICE® therapy application. — From enrollment up to 7 days after last ARTICE® treatment.

Trial sites (2)

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