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

ARTISTRY - ARTICE® Therapy Registry Study

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 Overview

• Status: Recruiting
• Conditions: Sepsis; Septic Shock; Immunoparalysis in Septic Shock

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Judith Gross, M. Sc.; Phone Number: +49 1772216033; Email: judith.gross@artcline.de
• Study Contact Backup: Name: Jens Altrichter, Dr. med.; Phone Number: +49 381 440 703 0; Email: jens.altrichter@artcline.de

Study Locations

• Germany
  • Magdeburg, Germany, 39130
    • Recruiting
    • Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin
    • Contact: Martin Sauer, Pof. Dr.; Phone Number: 3105 +49391791; Email: martin.sauer@klinikum-magdeburg.de
    • Contact: Georg Richter; Phone Number: 3105 +49391791; Email: georg.richter@Klinikum-Magdeburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay

Description

Inclusion Criteria:

• Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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	From enrollment up to 7 days after last ARTICE® treatment.
Hospital survival rates.		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)	From enrollment up to 7 days after last ARTICE® treatment.
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.	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.	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	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.	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	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	From enrollment up to 7 days after last ARTICE® treatment.
Complications related to the ARTICE® therapy application.		From enrollment up to 7 days after last ARTICE® treatment.

Collaborators and Investigators

• Sponsor: Artcline GmbH
• Investigators: Principal Investigator: Martin Sauer, Prof. Dr. med., Klinikum Magdeburg, Klinik für Intensiv- & Rettungsmedizin

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: septic shock; Sepsis; Immunoparalysis in Septic Shock
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Sepsis; Shock, Septic
• Other Study ID Numbers: ARTistry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No