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Recruiting NCT07388628

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

— Observational Sepsis Septic Shock Immunoparalysis in Septic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sepsis, Septic Shock, Immunoparalysis in Septic Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ARTISTRY - ARTICE® Therapy Registry Study

Overview

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.

Primary outcome measures

  • Change in SOFA score D0 to SOFA Score D7 (or after last ARTICE® treatment, if later as D7). [Time frame: From enrollment up to 7 days after last ARTICE® treatment.]
  • Changes in general SOFA score and SOFA sub scores. [Time frame: From enrollment up to 7 days after last ARTICE® treatment.]
  • Changes in standard lab and inflammatory biomarkers. [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. [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.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 2 centers
  • Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin — Magdeburg
  • Johannes Wesling Klinikum, Universitätsklinik für Anästhesiologie, Intensiv & Notfallmediz — Minden

Identifiers

NCT: NCT07388628 · ARTistry

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗