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.
Study Type
OBSERVATIONAL
Enrollment
200
Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin
Magdeburg, Germany
RECRUITINGChange 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)
Time frame: 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)
Time frame: 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
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
Hospital survival rates.
Time frame: 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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Time frame: From enrollment up to 7 days after last ARTICE® treatment.
Length of ICU stay (days).
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
Mechanical ventilation days.
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
Renal replacement therapy days.
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
Vasopressor therapy days.
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
Frequency of secondary infections.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
Complications related to the ARTICE® therapy application.
Time frame: From enrollment up to 7 days after last ARTICE® treatment.