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Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy

NCT05442710•Artcline GmbH

View on ClinicalTrials.gov

Summary

Evaluation of a novel therapy approach for severe sepsis patients. Subjects randomized into the treatment arm receive treatment with an immune cell perfusion system on top of standard care. This may contribute to the improvement of the impaired organ function of septic shock patients by assisting the impaired immune system (immune competence enhancement = ARTICE)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult subjects
•1. ≥ 18 years of age
•2. with septic shock, defined as those with septic shock according to" Sepsis-3-Definition" who additionally require norepinephrine at a dose of ≥ 0.15 mcg/kg/min (and/or vasopressin at any dose) for a minimum of 6 hours (within the last 48 hours), to maintain a MAP ≥65 mmHg
•3. Subjects ≥ 80 years of age shall have a Clinical Frailty Scale of \<5 to be enrolled.
•2. Fulfillment of the definition of septic shock, not longer than 48h before randomization. I.e. the 48h start at the end of the 6h period.
•3. Blood lactate \>2 mmol/L despite adequate volume resuscitation during the current sepsis episode
•4. Source control achieved / in progress in the judgement of the investigator
•5. Subjects are required to have central venous access and an arterial line, and these are expected to remain present for at least the initial 48 hours of study.
•6. Subjects must have received adequate volume replacement in the judgement of the investigator.
•7. Subject or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements or confirmation of the urgency of participation in the clinical trial and the possible benefit to the subject by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing centre to include subjects who are unable to provide informed consent.

Exclusion Criteria

•1. Acute or chronic leukemia,
•2. Bilirubin ≥ 2 mg/dL (≥33 µmol/L),
•3. Ongoing (concomitant) or prior within the last 6 month any chemotherapy or radiotherapy for malignancy,
•4. Autoimmune disease with systemic medication of ≥10 mg prednisolone equivalent,
•5. Previous transplantation,
•6. Subjects receiving interferon therapy (14 days prior randomisation),
•7. Acute pulmonary embolism within the last 72 hours,
•8. Ischemic stroke or intracranial bleeding within the last 3 months
•9. Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG within the last 72 hours,
•10. Cardiopulmonary resuscitation within last 7 days,
+15 more criteria

Locations (20)

Universitätsklinikum Freiburg, Interdisziplinäre Medizinische Intensivtherapie (IMIT)

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitätsklinikum Regensburg, Klinik für Anästhesiologie

Regensburg, Bavaria, Germany

Universitätsklinikum Bonn, Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin

Bonn, North Rhine-Westphalia, Germany

Universitätsklinikum Köln, Klinik für Anästhesiologie und Operative Intensivmedizin

Cologne, North Rhine-Westphalia, Germany

Helios Klinikum Aue

Aue, Saxony, Germany

Universitätsklinikum Leipzig, Klinik und PK für Anästhesiologie und Intensivtherapie

Leipzig, Saxony, Germany

Universitätsklinikum Halle (Saale), Universitätsklinik für Anästhesiologie und Operative Intensivmedizin

Halle, Saxony-Anhalt, Germany

UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, Germany

Charité Berlin, Klinik mit Schwerpunkt Nephrologie und internistische Intensivmedizin

Berlin, Germany

Klinikum Braunschweig, Medizinische Klinik V

Braunschweig, Germany

Key Dates

Start Date

July 24, 2022

Primary Completion Date

March 30, 2026

Completion Date

June 30, 2026

Last Updated

May 25, 2025

Enrollment

142

ESTIMATED participants

Conditions

Sepsis, Severe

Interventions

ARTICE

BIOLOGICAL

Contacts

Jens Altrichter, MD

CONTACT

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

Erdmann J Zippel, RN

CONTACT

*4915772371146 erdmann.zippel@artcline.de

Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm

NCT04850456

Critical IllnessSepsis, Severe

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COMPLETEDNA

Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock

NCT05357339

Sepsis, SevereSepsis+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy

Inclusion Criteria

Exclusion Criteria

Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm

Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock

The Effect pf Goal-directed De-escalation in ARDS on Organ Function and Mortality

Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments

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