ARTICE® real-world data collection for sepsis and septic shock
ARTISTRY - ARTICE® Therapy Registry Study
Artcline GmbH · NCT07388628
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Artcline GmbH (industry) |
| Locations | 1 site (Magdeburg) |
| Trial ID | NCT07388628 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are under 18, are not receiving ARTICE®, or have contraindications to the device are unlikely to benefit from participation.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay Exclusion Criteria: \-
Where this trial is running
Magdeburg
- Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin — Magdeburg, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis, Septic Shock, Immunoparalysis in Septic Shock, septic shock