Actively Recruiting
Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy
Led by Artcline GmbH · Updated on 2025-05-25
142
Participants Needed
20
Research Sites
205 weeks
Total Duration
On this page
Sponsors
A
Artcline GmbH
Lead Sponsor
Z
Zentrum für Klinische Studien Jena
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects aged 18 years or older
- Diagnosis of septic shock within the last 48 hours according to Sepsis-3 definition
- Requirement for norepinephrine at a dose of 0.15 mcg/kg/min or higher (and/or any dose of vasopressin) for at least 6 hours within the last 48 hours to maintain mean arterial pressure 6 mmHg
- Blood lactate level greater than 2 mmol/L despite adequate fluid resuscitation during the current sepsis episode
- Source control of infection achieved or in progress as judged by the investigator
- Presence of central venous access and an arterial line expected to remain for at least the initial 48 hours of the study
- Adequate volume replacement as judged by the investigator
- For subjects aged 80 years or older, a Clinical Frailty Scale score less than 5
- Willingness and ability of the subject or legal surrogate to provide written informed consent and comply with protocol requirements or confirmation of urgency and possible benefit by independent consultant or local procedures
You will not qualify if you...
- Acute or chronic leukemia
- Bilirubin level 2 mg/dL (33 mol/L) or higher
- Chemotherapy or radiotherapy for malignancy within the last 6 months or ongoing
- Autoimmune disease requiring systemic medication of 10 mg or more prednisolone equivalent
- Previous organ transplantation
- Interferon therapy within 14 days prior to randomization
- Acute pulmonary embolism within the last 72 hours
- Ischemic stroke or intracranial bleeding within the last 3 months
- Suspicion of acute coronary syndrome within the last 72 hours based on symptoms or ECG
- Cardiopulmonary resuscitation within the last 7 days
- Moribund condition with life expectancy less than 72 hours
- Presence of do-not-resuscitate or do-not-intubate orders
- Known HIV infection or chronic viral hepatitis
- Isolated urosepsis
- Pregnancy or nursing period
- Primary cause of hypotension not due to sepsis (e.g., major trauma, burns, heart failure)
- Previous sepsis with ICU admission during current hospital stay
- Known or suspected acute mesenteric ischemia
- Chronic mechanical ventilation or severe COPD requiring daily oxygen or recent mechanical ventilation
- Decision to limit full care prior to consent
- Prior enrollment in this trial
- Use of investigational drugs or devices within last month or concurrent clinical trial participation
- Multiple injuries including polytrauma and burns over 20% total body surface area
- Diagnosed pre-existing dementia
- Severe COVID-19 pneumonia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Universitätsklinikum Freiburg, Interdisziplinäre Medizinische Intensivtherapie (IMIT)
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Withdrawn
2
Universitätsklinikum Regensburg, Klinik für Anästhesiologie
Regensburg, Bavaria, Germany, 93053
Actively Recruiting
3
Universitätsklinikum Bonn, Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
4
Universitätsklinikum Köln, Klinik für Anästhesiologie und Operative Intensivmedizin
Cologne, North Rhine-Westphalia, Germany
Actively Recruiting
5
Helios Klinikum Aue
Aue, Saxony, Germany, 08280
Actively Recruiting
6
Universitätsklinikum Leipzig, Klinik und PK für Anästhesiologie und Intensivtherapie
Leipzig, Saxony, Germany, 04103
Actively Recruiting
7
Universitätsklinikum Halle (Saale), Universitätsklinik für Anästhesiologie und Operative Intensivmedizin
Halle, Saxony-Anhalt, Germany, 06120
Actively Recruiting
8
UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Actively Recruiting
9
Charité Berlin, Klinik mit Schwerpunkt Nephrologie und internistische Intensivmedizin
Berlin, Germany, 10117
Actively Recruiting
10
Klinikum Braunschweig, Medizinische Klinik V
Braunschweig, Germany, 38126
Actively Recruiting
11
Universitätsklinikum Essen, Klinik für Nephrologie
Essen, Germany, 45147
Actively Recruiting
12
University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy
Frankfurt, Germany, 69590
Not Yet Recruiting
13
Helios Klinikum HIldesheim
Hildesheim, Germany, 31135
Actively Recruiting
14
Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin
Magdeburg, Germany, 39130
Actively Recruiting
15
University Medical Center Mainz, Study center for Anesthesiology
Mainz, Germany, 55131
Actively Recruiting
16
Universitätsklinikum Mannheim
Mannheim, Germany, 69167
Actively Recruiting
17
University Hospital Minden, Departmenr of Anaesthesiology, intensive and emergency care
Minden, Germany, 32429
Actively Recruiting
18
Klinikum Oldenburg, Universitätsklinik für Anästhesiologie/ Intensivmedizin
Oldenburg, Germany, 26133
Actively Recruiting
19
Universitätsmedizin Rostock, Abteilung KAI
Rostock, Germany
Actively Recruiting
20
Helios Kliniken Schwerin, Department for intensive care
Schwerin, Germany, 19055
Actively Recruiting
Research Team
J
Jens Altrichter, MD
CONTACT
E
Erdmann J Zippel, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here