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

NCT05442710 | Recruiting Phase 2 DMC

• 1 other identifier: ReActIF-ICE_ZKSJ0124
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 20

Brief 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)

Conditions

Sepsis, Severe

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of the ARTICE therapy, composed of new onset of serious adverse events from re-evaluation on Day 2 through Day 28

  The number \[n\] of new onsets of serious adverse events (SAEs) from re-evaluation-Day 2 through Day 28 will be counted in both arms and the difference between groups will be compared.

  From re-evaluation on Day 2 through Day 28

Secondary Outcomes (23)

• All cause mortality through Day 28

  From re-evaluation on Day 2 through Day 28

• All cause mortality through Day 90

  From re-evaluation on Day 2 through Day 90

• All-cause in-hospital mortality

  From re-evaluation on Day 2 through until hospital discharge

• Daily changes in total SOFA and SOFA sub-scores

  Until Day 10

• Time course of key inflammatory/ immunological markers in between the two groups.

  From re-evaluation on Day 2 until Day 28

Study Arms (2)

ARTICE Treatment Group

EXPERIMENTAL

Subjects with septic shock treated with immune cell extracorporeal therapy on top of standard of care

Biological: ARTICE

Control Group

NO INTERVENTION

Subjects with septic shock receiving standard of care

Interventions

ARTICE BIOLOGICAL

Extracorporal treatment with purified granulocyte concentrate

ARTICE Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects
• ≥ 18 years of age
• 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
• Subjects ≥ 80 years of age shall have a Clinical Frailty Scale of \<5 to be enrolled.
• 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.
• Blood lactate \>2 mmol/L despite adequate volume resuscitation during the current sepsis episode
• Source control achieved / in progress in the judgement of the investigator
• 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.
• Subjects must have received adequate volume replacement in the judgement of the investigator.
• 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.

You may not qualify if:

• Acute or chronic leukemia,
• Bilirubin ≥ 2 mg/dL (≥33 µmol/L),
• Ongoing (concomitant) or prior within the last 6 month any chemotherapy or radiotherapy for malignancy,
• Autoimmune disease with systemic medication of ≥10 mg prednisolone equivalent,
• Previous transplantation,
• Subjects receiving interferon therapy (14 days prior randomisation),
• Acute pulmonary embolism within the last 72 hours,
• Ischemic stroke or intracranial bleeding within the last 3 months
• Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG within the last 72 hours,
• Cardiopulmonary resuscitation within last 7 days,
• Moribund subject (life expectancy \<72 hours), in the judgement of the investigator
• Presence of a do-not-resuscitate or do-not-intubate order,
• Known HIV infection or chronic viral hepatitis,
• Isolated Urosepsis,
• Pregnancy/nursing period,

Sponsors & Collaborators

• Artcline GmbH: lead
• Zentrum für Klinische Studien Jena: collaborator
• RQM+: collaborator

Study Sites (20)

Universitätsklinikum Freiburg, Interdisziplinäre Medizinische Intensivtherapie (IMIT)

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

WITHDRAWN

Universitätsklinikum Regensburg, Klinik für Anästhesiologie

Regensburg, Bavaria, 93053, Germany

RECRUITING

Universitätsklinikum Bonn, Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Universitätsklinikum Köln, Klinik für Anästhesiologie und Operative Intensivmedizin

Cologne, North Rhine-Westphalia, Germany

RECRUITING

Helios Klinikum Aue

Aue, Saxony, 08280, Germany

RECRUITING

Universitätsklinikum Leipzig, Klinik und PK für Anästhesiologie und Intensivtherapie

Leipzig, Saxony, 04103, Germany

RECRUITING

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

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Charité Berlin, Klinik mit Schwerpunkt Nephrologie und internistische Intensivmedizin

Berlin, 10117, Germany

RECRUITING

Klinikum Braunschweig, Medizinische Klinik V

Braunschweig, 38126, Germany

RECRUITING

Universitätsklinikum Essen, Klinik für Nephrologie

Essen, 45147, Germany

RECRUITING

University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy

Frankfurt, 69590, Germany

NOT YET RECRUITING

Helios Klinikum HIldesheim

Hildesheim, 31135, Germany

RECRUITING

Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin

Magdeburg, 39130, Germany

RECRUITING

University Medical Center Mainz, Study center for Anesthesiology

Mainz, 55131, Germany

RECRUITING

Universitätsklinikum Mannheim

Mannheim, 69167, Germany

RECRUITING

University Hospital Minden, Departmenr of Anaesthesiology, intensive and emergency care

Minden, 32429, Germany

RECRUITING

Klinikum Oldenburg, Universitätsklinik für Anästhesiologie/ Intensivmedizin

Oldenburg, 26133, Germany

RECRUITING

Universitätsmedizin Rostock, Abteilung KAI

Rostock, Germany

RECRUITING

Helios Kliniken Schwerin, Department for intensive care

Schwerin, 19055, Germany

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Reuter, Prof.Dr.

  University Hospital Rostock

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Altrichter, MD

CONTACT

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

Erdmann J Zippel, RN

CONTACT

*4915772371146; erdmann.zippel@artcline.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, randomized, controlled parallel-group study

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: July 5, 2022
• Study Start: July 24, 2022
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (20)