ARTICE® Real Data Collection & Observational Trial, Phase 4 Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorArtcline GmbH
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay
Disqualifiers
None
Trial population
Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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)
Time frame
From enrollment up to 7 days after last ARTICE® treatment.2
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.3
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.4
Hospital survival rates.
Time frame
From enrollment up to 7 days after last ARTICE® treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov