ARTICE® real-world data collection for sepsis and septic shock
Official title: ARTISTRY - ARTICE® Therapy Registry Study
Run by Artcline GmbH · NCT07388628 · Data updated 2026-11-12
This registry will collect real-life information on using ARTICE® in adults with sepsis or septic shock to see how well the treatment works and how safe it is.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Artcline GmbH Industry-sponsored |
| Locations | 2 sites (Magdeburg and 1 other locations) |
| Status | Recruiting |
| Started | September 25, 2025 |
| Main results expected | September 2027 |
| Study ends | December 2027 |
| Registry record updated | July 15, 2026 |
| Trial ID | NCT07388628 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older admitted to the ICU with sepsis or septic shock who are planned to receive ARTICE® treatment are the intended participants.
✕Probably not a fit
Patients who are under 18, are not receiving ARTICE®, or have contraindications to the device are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 observational registry will record real-world clinical data on adult ICU patients treated with ARTICE® for sepsis, septic shock, or related immunoparalysis. Sites will collect baseline characteristics, treatment details, safety events, and clinical outcomes including SOFA score changes from day 0 to day 7. The project aims to identify patient subgroups with differing risk–benefit profiles and to document routine use patterns outside controlled trials. Initial enrollment is planned at participating hospitals offering ARTICE®, starting with Klinikum Magdeburg.
Why it matters
Potential benefit: If successful, the registry could show whether ARTICE® improves short-term organ function and has an acceptable safety profile for sepsis patients treated in routine ICU care.
How similar studies have gone: ARTICE® has prior clinical use and this phase 4 registry builds on that experience, but large randomized trials showing clear benefit in sepsis are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay Exclusion Criteria: \-
Where it's running
-
Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin
Magdeburg, Germany Recruiting -
Johannes Wesling Klinikum, Universitätsklinik für Anästhesiologie, Intensiv & Notfallmedizin
Minden, Germany Recruiting
Study contacts
- Principal investigator: Martin Sauer, Prof. Dr. med. — Klinikum Magdeburg, Klinik für Intensiv- & Rettungsmedizin
- Study coordinator: Jens Altrichter, Dr. med.
- Email: jens.altrichter@artcline.de
- Phone: +49 381 440 703 0
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.