NCT07388628

Brief Summary

The objectives of this registry study are to:

  1. 1.Record real-life data related to the use of the ARTICE® therapy in sepsis subjects.
  2. 2.Further evaluate ARTICE® treatment efficacy.
  3. 3.Identify potential sub-groups, assess their risk-benefit- and safety profile.
  4. 4.Changes in SOFA score D0 to SOFA Score D7.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Sep 2025Dec 2027

Study Start

First participant enrolled

September 25, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

January 5, 2026

Last Update Submit

February 6, 2026

Conditions

SepsisSeptic ShockImmunoparalysis in Septic Shock

Keywords

Sepsisseptic shockImmunoparalysis in Septic Shock

Outcome Measures

Primary Outcomes (16)

  • 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin

Magdeburg, 39130, Germany

RECRUITING

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Martin Sauer, Prof. Dr. med.

    Klinikum Magdeburg, Klinik für Intensiv- & Rettungsmedizin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Altrichter, Dr. med.

CONTACT

+49 381 440 703 0jens.altrichter@artcline.de

Judith Gross, M. Sc.

CONTACT

+49 1772216033judith.gross@artcline.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

February 5, 2026

Study Start

September 25, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

DE(1)