SepsisARTistryNCT07388628
ARTICE® Real Data Collection & Observational Trial, Phase 4 Study
An observational study of Sepsis and Septic Shock, run by Artcline GmbH at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Immunoparalysis in Septic Shock
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- 25 Sep 2025to Dec 2027
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay
Who may be able to join
- Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin
Magdeburg, 39130
Martin Sauer, Pof. Dr., +49391791 ext. 3105, martin.sauer@klinikum-magdeburg.de
Georg Richter, +49391791 ext. 3105, georg.richter@Klinikum-Magdeburg.de
- Recruiting
Johannes Wesling Klinikum, Universitätsklinik für Anästhesiologie, Intensiv & Notfallmedizin
Minden, 32429
Christina Zeichen, Dr., +49 571 790 51030, Christina.Zeichen@muehlenkreiskliniken.de
Julia Larisch, Dr.
About this study
Official title: ARTISTRY - ARTICE® Therapy Registry Study
The objectives of this registry study are to:
- Record real-life data related to the use of the ARTICE® therapy in sepsis subjects.
- Further evaluate ARTICE® treatment efficacy.
- Identify potential sub-groups, assess their risk-benefit- and safety profile.
- Changes in SOFA score D0 to SOFA Score D7.
- Conditions
- Sepsis, Septic Shock, Immunoparalysis in Septic Shock
- Keywords
- Sepsis, septic shock, Immunoparalysis in Septic Shock
- Medical subject headings
- Sepsis, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: From enrollment up to 7 days after last ARTICE® treatment.
Hospital survival rates.
Measured: 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)
Measured: From enrollment up to 7 days after last ARTICE® treatment.
Length of ICU stay (days).
Measured: From enrollment up to 7 days after last ARTICE® treatment.
Mechanical ventilation days.
Measured: From enrollment up to 7 days after last ARTICE® treatment.
Renal replacement therapy days.
Measured: From enrollment up to 7 days after last ARTICE® treatment.
Vasopressor therapy days.
Measured: From enrollment up to 7 days after last ARTICE® treatment.
Frequency of secondary infections.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: From enrollment up to 7 days after last ARTICE® treatment.
Complications related to the ARTICE® therapy application.
Measured: From enrollment up to 7 days after last ARTICE® treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start25 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Artcline GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Sauer, Prof. Dr. med., Principal investigator, Klinikum Magdeburg, Klinik für Intensiv- & Rettungsmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388628
- Sponsor's protocol ID
- ARTistry
- Acronym
- ARTistry
- Status last verified
- Jul 2026
- First submitted
- 5 Jan 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTISTRY - ARTICE® Therapy Registry Study
- ClinicalTrials.gov ID
- NCT07388628
- Acronym / sponsor ID
- ARTistry / ARTistry
- Conditions
- Sepsis, Septic Shock, Immunoparalysis in Septic Shock
- Keywords
- Sepsis, septic shock, Immunoparalysis in Septic Shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Artcline GmbHIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this registry study are to:
- Record real-life data related to the use of the ARTICE® therapy in sepsis subjects.
- Further evaluate ARTICE® treatment efficacy.
- Identify potential sub-groups, assess their risk-benefit- and safety profile.
- Changes in SOFA score D0 to SOFA Score D7.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay
Key inclusion criteria (1 listed)
- Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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)
Changes in general SOFA score and SOFA sub scores.
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
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)
Changes in standard lab and inflammatory biomarkers.
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
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
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.
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)
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.
Type of secondary infections: it will be divided into viral, bacterial or fungi infection.
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
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.
Changes in the physiological parameter heartrate.
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
as physiological parameter will be measured heartrate in bpm
Changes in physiological parameter blood pressure.
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
as physiological parameter will be measured systolic and diastolic blood pressure in mmHg.
Changes in physiological parameter body temperature.
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
as physiological parameter will be measured body temperature in °C
Changes in physiological parameter mean arterial pressure.
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
as physiological parameter will be measured mean arterial pressure in mmHG
Complications related to the ARTICE® therapy application.
Time frame: From enrollment up to 7 days after last ARTICE® treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Sauer, Prof. Dr. med. principal investigator
Klinikum Magdeburg, Klinik für Intensiv- & Rettungsmedizin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Artcline GmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Altrichter, Dr. med. (+49 381 440 703 0, jens.altrichter@artcline.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.